A pelvic health device originally designed to manage bladder leaks has received an expanded indication, allowing it to also be used for menstrual fluid collection - marking a rare example of a dual-purpose product spanning continence and period care.

US-based Watkins-Conti announced that its Yōni.Fit bladder support device can now be used to collect menstrual fluid and vaginal discharge in women with stress urinary incontinence (SUI). The silicone insert, which is available by prescription, was previously cleared by the FDA in 2024 for temporary management of SUI.

Stress urinary incontinence - the involuntary leakage of urine during activities such as exercise, coughing or laughing - affects an estimated two in three women at some point in their lives. Despite its prevalence, it remains underdiagnosed and often managed separately from other aspects of pelvic and reproductive health.

The updated indication reflects growing interest in more integrated approaches to women’s health, where products are designed to address overlapping needs rather than single conditions in isolation.

“Women have inquired about using the Yōni.Fit device during their menstrual period since it was first introduced for SUI,” said Allison Watkins, founder and CEO of Watkins-Conti Products.

Yōni.Fit is a reusable, self-administered vaginal insert available in multiple sizes, and is designed to be worn for up to 12 hours. According to clinical trial data, the device reduced bladder leaks in over 96% of participants, with no serious device-related adverse events reported.

The move also comes as menstrual cups and reusable products continue to gain traction, particularly among younger consumers, driven by cost, sustainability and convenience. According to a study from the Harvard Chan School of Public Health, approximately 20% of menstruating women in the United States report using a menstrual cup.

While the addition of a menstrual indication does not change the device’s core function, it highlights a broader shift in product design - moving towards solutions that better reflect how women experience pelvic health across different life stages and conditions.

Sun Pharmaceutical Industries has agreed to acquire Organon in an all-cash deal valuing the women’s health-focused pharmaceutical company at $11.75 billion, in one of the largest transactions in the sector in recent years.

Under the terms of the agreement, India’s Sun Pharma will acquire all outstanding shares of Organon for $14.00 per share, with the transaction expected to close in early 2027, subject to regulatory and shareholder approvals.

Organon, which was spun out of Merck in 2021, has built one of the largest dedicated women’s health portfolios globally, with more than 70 products spanning contraception, fertility and menopause, alongside a broader established medicines and biosimilars business. The company operates in over 140 countries.

The acquisition will position the combined business among the top 25 pharmaceutical companies globally by revenue, while creating what Sun Pharma describes as a top-three player in women’s health.

For Sun Pharma, the deal represents a significant expansion into women’s health and biosimilars, as well as strengthening its position in branded generics and established medicines, and providing it with a more global footprint.

Dilip Shanghvi, Executive Chairman of Sun Pharma, said,

“Organon’s portfolio, capabilities and global reach are highly complementary to our own, and we believe that bringing the two organizations together can create a stronger and more diversified platform.

“We have deep respect for Organon’s mission and look forward to building on its legacy while driving sustainable long‑term growth.”

Organon’s leadership said the deal followed a strategic review of options and would deliver immediate value to shareholders, while enabling continued expansion of its women’s health offering under new ownership.

Carrie Cox, Executive Chair of Organon, commented,

“Following a comprehensive review of strategic alternatives, our Board determined that this all‑cash transaction offers compelling and immediate value to Organon stockholders.

“We believe Sun Pharma is well positioned to support Organon’s businesses, employees and patients globally, and to further advance our commitment to delivering impactful medicines and solutions.”

The acquisition comes at a time of growing investment and attention in women’s health, but also ongoing questions around scale, sustainability and ownership of the category. Since its spinout, Organon has been one of the few large pharmaceutical companies with a dedicated focus on women’s health, positioning itself around conditions that uniquely, disproportionately or differently affect women.

The deal is a positive signal that large pharmaceutical players want to consolidate and build scale in women’s health - a category that has historically been fragmented and underfunded relative to other areas of healthcare.

Following completion, the combined company is expected to have a presence in more than 150 countries and a significantly expanded commercial platform across both developed and emerging markets.

Combined revenues for the two companies is expected to exceed $12.4b.

The deal follows last year’s failed acquisition of Mayne Pharma by Cosette for a proposed $425m following regulatory pushback.

A woman in her early 60s slips, falls, and breaks her hip. Within a year, there’s a one in five chance she won’t survive.

And yet, for most of her life, bone health was barely part of the conversation.

But there are early signs of change.

Bone health is beginning to converge with the longevity boom - moving away from fractures in later life and into a much earlier window that the system isn’t currently built to manage.

At the same time, there are growing signs of commercial momentum. Earlier this month, Osteoboost Health raised $8 million to scale its wearable that targets low bone density before osteoporosis.

And telehealth clinic Hone Health announced it has pulled BodySpec’s DEXA scans into its longevity platform - bringing testing for bone density into much earlier data-driven care.

In this new FutureFemHealth Pro piece, I break down what’s actually changing in bone health - from earlier clinical risk and the rise of strength training, to the emerging stack of diagnostics, interventions and support.

And why, despite it all, the most important layer of this market is still missing.

Bone health is moving earlier. But the system and market around it are still mostly built for late stage care. That’s a major opportunity to connect early risk to sustained action.

Read more

🌟 In this week’s briefing:

• 🦴 Osteoboost raises $8M for first FDA-cleared wearable targeting bone loss

• ❤️ Septagen targets overlooked cardiovascular risk in women with precision biotech platform

• ✅ ENDOSURE secures CE mark for 30-minute endometriosis test that can be used from teenage years through to post-menopause

• 👩🏽‍💻 UK strategy refresh lands - as US women’s health research funding falls 31%

Share your news: anna@futurefemhealth.com

But first…Q1 in review

Women’s health raised $1.24 billion in Q1 - but nearly half came from a single deal (WHOOP). Strip that out and the Q1 figure drops to $665.

In case you missed it, in our first FutureFemHealth Pro feature I break down five key signals - from the rise of doula care to the shift towards deeper tech like menstrual blood diagnostics, and what it means for where the market goes next.

Companies like gastrointestinal care and migraine are serving majority populations - often 80% women - without being labelled as femtech.

If we don’t track this properly, a large part of women’s health innovation stays invisible.

Read the full breakdown - available inside FutureFemHealth Pro - and download our complete Q1 funding tracker here:

Explore the Q1 insights

💰 Capital flows

📌 US: Osteoboost raises $8M to scale FDA-cleared wearable targeting bone loss in postmenopausal women. The prescription device delivers vibration therapy to the hips and spine and is positioned as the first non-drug treatment for osteopenia - the precursor to osteoporosis and a stage where there are currently no approved pharmaceutical options. This round was led by Ambit Health Ventures. (Continue reading: FutureFemHealth)

📌 THE NETHERLANDS: ScreenPoint Medical raises €13.6M to scale AI-powered breast cancer detection platform. The Transpara platform supports radiologists in identifying cancers earlier and prioritising high-risk cases, and is already deployed in 30+ countries. It’s another example of AI embedding into clinical workflows - not replacing clinicians but acting as a ‘second pair of eyes’ to improve accuracy and efficiency. €11.9 million of the round came from existing investors Insight Partners and Siemens Healtineers, with a further €1.7 million in non-dilutive grants. The company will use funding to support product innovation and global expansion. (Continue reading: EU-startups)

🌟 Industry moves and strategic shifts

📌 US: Septagen launches to develop a drug and diagnostic platform targeting cardiovascular risk in postmenopausal women. Cardiovascular disease is the leading cause of death in women, but treatment has largely remained one-size-fits-all and often based on male physiology. This new approach from a Vanderbilt University-spinout targets thromboinflammatory risk - a platelet-driven mechanism linked to estrogen decline - using a blood test to identify women at elevated risk, followed by a once-daily oral drug designed to address that specific pathway alongside existing treatments. While still preclinical, it could bring precision medicine and a more targeted approach to an area of women’s health that’s long lacked specific therapies.(Continue reading: FutureFemHealth)

📌 EU: ENDOSURE receives CE mark for a non-invasive endometriosis test designed to deliver results in 30 minutes. This test can be used across all ages, including adolescents and postmenopausal women - extending beyond existing diagnostics which often limit to ages 18–43. With diagnosis still often delayed for years - and reliant on invasive procedures like laparoscopy - the company is positioning this as a first-line tool that could enable earlier detection and intervention, particularly in younger patients where the disease often begins. Clinical validation and real-world performance is still evolving - and will be key to determining the role of tests like these in practice. (Continue reading: FutureFemHealth)

📌 GERMANY: Hello Inside is partnering with insurer Barmer to offer a metabolic health programme to over 9 million members. Bringing continuous glucose monitoring into mainstream care, users will track their blood sugar alongside lifestyle factors, with AI translating that data into personalised recommendations. The company is applying this specifically to women’s health - across areas like PMS, menopause and energy - where underlying metabolic issues are often missed. (Continue reading: Tech.eu)

📌 US: Progyny launches a fully insured fertility and women’s health plan for small employers, moving beyond its traditional large, self-insured client base. The new fixed-cost model aims to lower the barrier to offering fertility benefits and open access to a much larger segment of the workforce. Small employers represent a significant untapped segment in the US, with around 50 million people working in organisations that have historically lacked access to fertility benefits. It moves fertility on from being just a premium perk at the largest companies to something that could be available as standard. (Continue reading: Fierce Healthcare)

📌 US: Wisp partners with Visby Medical to offer FDA-authorized at-home PCR STI testing with integrated telehealth follow-up. This model combines fast, lab-quality diagnostics (results in ~30 minutes) with immediate access to treatment, shortening the time from testing to care into a single at-home pathway. While not entirely new, it’s a good example of how women’s health is now starting to benefit from more integrated test, diagnose and treat models that reduce friction for patients. This is especially important in areas like sexual health where speed, privacy and stigma are still key barriers to seeking out help. (Continue reading: Med City News)

📌 EU: FertilAI secures CE mark for AI tools designed to optimise timing decisions during fertility treatment cycles. The Fertilane platform integrates into clinic workflows and uses data from 100,000+ cycles to predict ovulation and oocyte yield, helping clinicians determine the optimal moment for intervention. The focus on timing targets one of the most complex and variable parts of fertility care - while also helping clinics manage capacity and reduce monitoring burden. It signals growing use of AI not just for diagnosis, but for real-time decision support within treatment pathways. (Continue reading: FutureFemHealth)

📌 First confirmed pregnancy using BAIBYS’ AI system that selects and isolates sperm in IVF. This is a first-in-human milestone for fully automated sperm selection - because while AI tools are already used in IVF to support sperm and embryo selection, these systems typically guide embryologists rather than replace them at this part of the process. The procedure was carried out in Paris in December 2025, involving a 37-year-old patient, with the pregnancy now confirmed beyond the first trimester. (Continue reading: FutureFemHealth)

📊 From FutureFemHealth Intelligence

📌 NEW REPORT: The women’s health wearables landscape. Wearables in women’s health are arguably still ‘early’ - but so is the system they’re trying to improve. As devices move beyond fitness into areas like menstrual health, menopause and pelvic care, they’re beginning to generate something that has historically been missing: continuous, real-world data on women’s bodies. This report, written by women’s health strategist Anastasiya Markvarde, maps the emerging landscape from head to toe. (Continue reading: FutureFemHealth)

🩸 Research and women’s health news

📌 UK/AUS: New Lancet review finds “brain fog” affects two-thirds of women during menopause - yet remains under-researched and poorly understood. Cognitive changes are a major area of unmet need in menopause research. Symptoms like memory loss and reduced concentration impact confidence, work and day-to-day functioning for many women, but we don’t know why or what types of support or treatment could be effective. Importantly, symptoms are also hard to quantify or measure - which means it’s easier for the system to ignore or dismiss them. “I hear all the time from women who have gone through menopause that validation would have made a significant difference to their resilience and the approach they took to living with menopause.” says lead researcher Dr Caroline Gurvich (Continue reading: UCL / The Lancet)

📌 CANADA: Survey of 1,000 women finds gaps in reproductive health knowledge, diagnosis and care have remained unchanged across generations. Women across age groups are still experiencing near identical challenges in access to care — suggesting that despite growing attention on women’s health, the system itself has not meaningfully improved. More than half of respondents said their symptoms were initially dismissed, while over 60% needed multiple providers to get answers. The findings point to a broader issue beyond access: a lack of information and preparation, with over half saying sex education did not prepare them for adult reproductive health and many delaying care because they were unsure their symptoms were serious enough. (Continue reading: FutureFemHealth)

📄 Policy watch: risks and opportunities

📌 UK: England’s Women’s Health Strategy to include £1.5m femtech fund as refresh focuses on patient voice and waiting lists. The long-awaited update of the original 2022 women’s health strategy came with some blunt honesty from Health Secretary Wes Streeting as he said the NHS “too often gaslights women, treating their pain as an inconvenience and their symptoms as an overreaction.” A small £1.5m Femtech fund (with limited detail so far) sits within a wider push to support tech adoption - but may point to the immediate priority being cultural and system change instead. Other notable points include a requirement for publicly funded research to account for sex-based differences, and plans to trial wearables in areas of deprivation, initially focused on cardiovascular disease. (Continue reading: FutureFemHealth)

📌 US: Scientific research funding in the U.S. is shrinking, according to an analysis by The Washington Post. Analysis of NIH grant data is showing that ~15% fewer competitive grants were awarded and more than 2,700 fewer projects funded so far this year. Women’s health has been hit particularly hard, with a 31% drop in funded projects, while labs face hiring freezes, reduced PhD admissions and early-career researchers struggling to secure funding. The impact here is long-term, creating a weaker pipeline that will have knock-on impacts for years to come. (Continue reading: Washington Post)

📌 US: Perelel founder pushes for benefits change for postpartum support. Around one-third of Americans utilize HSA/FSA benefits to subsidize their spending on approved goods (which includes things like the Oura Ring and infrared sauna blankets). Yet, the tax code largely covers a woman’s health only before giving birth, an underlying disconnect between government regulation and women’s health standards. Perelel founder Alex Taylor is campaigning to make postnatal vitamins HSA- and FSA-eligible, in the same way that prenatal vitamins already are. (Continue reading: Fortune)

📆 Save the date

📌 VIRTUAL: Menopause 2.0 ‘Understanding perimenopause before menopause’. May 6. Women of Wearable’s third annual virtual conference on menopause, this year featuring speakers from Natural Cycles, Amissa Health, Mayo Clinic and more. 🎟️ Use code ‘FUTUREFEMHEALTH’ at the checkout for a free ticket here.

📌AUSTRALIA: Breaking the silos: the women’s health medtech summit. Sydney, May 27-28. This inaugural event is dedicated to addressing long-standing gaps in research, innovation, and policy affecting women’s health in Australia. The program brings together leading voices shaping the national conversation on women’s health in MedTech - spanning media, policy, research, and industry - to drive real system change. 🎟️ Tickets here.

That’s all for this week! If you’ve missed any previous newsletter issues catch them all at futurefemhealth.com and do make sure to follow us on LinkedIn and you can connect with me directly.

Anna

This newsletter is for informational purposes only and should not be considered medical or financial advice.

In recent years there’s been a transformation in the wearables space as they shift from designs centred around male athletes and sports performance to instead including - and sometimes even leading with - a female-focused approach.

In a new FFHi report, written by women’s health strategist Anastasiya Markvarde, we share a curated map to describe every major category of women’s health wearable - literally from head to toe - mapping them onto a silhouette of a pregnant woman.

While most devices included in the article serve women at all life stages and go further beyond fertility, the pregnant woman’s body concentrates one of the fullest spectrums of physiological demands these devices address: cardiovascular shifts, hormonal flux, sleep disruption, pelvic load, fetal wellbeing, and postural change.

As always, this map highlights some of the leading devices in the area and is non-exhaustive. We welcome your feedback on the recommended additions to our list!

Why are “imperfect” wearables worth our attention?

Before we dive into the wearables landscape, let’s address the ‘imperfection’ of these devices and the early stage of development.

Wearables are routinely criticised for being imprecise, not FDA-approved, or insufficiently validated in large clinical trials. While this is a legitimate scientific standard to hold it must be weighed against the actual state of healthcare for women, which is far from perfect itself.

It’s a context we know all too well: conditions like endometriosis take an average of seven to ten years to diagnose. If hormonal treatments are not an option, then patients are left with virtually no alternatives. Conditions like heavy menstrual bleeding (HMB) remain very difficult to diagnose and treat because clinical evaluation often relies on subjective recall (like estimating pad usage or even simply asking the patient’s perception).

And this is compounded by the systemic dismissal of women’s pain and gaps in standard care which are a real emergency. In the UK, the Government’s updated Women’s Health Strategy, announced in April 2026 acknowledges that the NHS, “too often gaslights women, treating their pain as an inconvenience and their symptoms as an overreaction.”

In this context, the argument that women should wait for “perfectly validated” wearables before using them sets a standard that our healthcare systems have never been held to when treating women.

Clearly, wearables should not replace clinical judgment or be used as standalone diagnostic tools. But what they can do is to offer more insights about women’s bodies, support women with continuous data about their health (something that wasn’t previously available), or provide a potential therapeutic alternative.

With that framing in place, here is our map….

1.On the ear: smart earrings & auricular neurostimulation

The ear is emerging as a strong site for wearable sensing.

It has rich, consistent blood flow, which makes temperature readings more stable than the wrist, and it also connects directly to the autonomic nervous system via the ear’s nerves. Early validation studies show that ear-based wearables can estimate core temperatures within around ±0.3–0.4°C when combining multiple sensors - that’s broadly in line with, or better than, many wrist-based devices. But accuracy still varies between individuals and needs more work.

There’s also a growing evidence base behind using the ear for vagus nerve stimulation. Systematic reviews now cover more than 40 randomised trials across depression, chronic pain, epilepsy, and insomnia, with several studies showing clinically meaningful improvements in symptoms. That said, the evidence is still mixed and larger, more consistent trials are needed

• Incora smart earrings: Incora has developed wearable earrings that provide insights based on the menstrual cycle, heart rate, sleep, and offer continuous temperature via in-ear sensors. Having achieved a special mention as a TIME Best Invention of 2025, the device is currently in waitlist phase with no confirmed commercial launch date.

• Lumia smart earrings: Lumia’s device tracks blood flow to the head - not just the usual wearable metrics like heart rate or sleep. The latest Lumia 2 builds on earlier versions originally created for patients with POTS (postural orthostatic tachycardia syndrome) and long COVID, both conditions where blood circulation to the brain doesn’t work properly, leading to symptoms like dizziness, fatigue, brain fog and fainting. Lumia’s sales started in November 2025 in the US and Canada at a $249 retail price plus a $10 monthly subscription, and is being sold primarily through an early-access reservation system.

• OhmBody auricular neurostimulation device: OhmBody is a consumer earpiece wellness device that uses neurostimulation to target nerve pathways and relieve menstrual symptoms without drugs or hormones. The underlying neuromodulation platform has received FDA clearance for specific medical indications (such as opioid withdrawal), but OhmBody itself is marketed as a wellness product. In early small studies, 88% of participants experienced greater menstrual comfort, with an average 55% reduction in menstrual blood loss and 71% reporting emotional stability. The device was showcased at CES 2026 and is available for sale priced at $559 for the starter kit.

2. On the head: neurostimulation headbands for cycle & sleep

Brain-directed interventions represent an innovative area in women’s health.

Most treatments today for menstrual pain focus on symptoms (pain relief, sleep aids, antidepressants). But brain-directed interventions try to target the underlying cause of conditions like PMS, PMDD and menopausal insomnia - namely how hormonal changes affect brain activity. Head-worn devices are therefore moving beyond consumer “meditation aids” into targeted neuromodulation for women’s health. Many startups use techniques like tDCS (mild electrical stimulation) or EEG-guided feedback to influence brain regions linked to pain, mood and sleep - positioning themselves as alternatives or add-ons to medications.

• Samphire Neuroscience cycle and pain headband: Samphire Neuroscience has developed a headband that uses mild electrical stimulation to reduce menstrual pain and mood symptoms by stimulating brain regions involved in pain perception and emotional regulation. The device is worn for 20 minutes daily during the days before menstruation ,guided by a companion mobile app. The product is marketed as Nettle™ in the UK/EU and Lutea™ in the U.S., with retail prices around €420 - €600, and is currently being investigated in clinical studies for conditions including PMDD, endometriosis-related pain, and menopause-associated symptoms. In early company-reported clinical testing, users of the active device experienced an average 52% reduction in menstrual pain compared with baseline or sham stimulation, supporting further clinical trials.

• Flow Neuroscience neuromodulation wearable for depression: Flow Neuroscience has developed a wearable neuromodulation headset designed to treat depression using transcranial direct current stimulation (tDCS). The device delivers a mild electrical current to the brain region involved in mood regulation, while a companion mobile app provides behavioural therapy guidance and treatment tracking. The headset has been CE-marked in Europe and the UK for depression treatment for several years and in 2025 the company received FDA approval for at-home treatment of major depressive disorder, with U.S. launch expected in 2026. This FDA approval has been a significant milestone for the overall potential of tDCS.

  Clinical evidence supporting the system includes randomized controlled trials in which patients completed a 10-week course of daily 30-minute stimulation sessions, demonstrating remission rates significantly higher than placebo conditions in company-sponsored studies. The Flow headset is currently commercially available across the UK and Europe, typically priced around €459 for the full system including the stimulation device and app-based therapy program. Beyond general depression treatment, Flow has increasingly focused on women’s mental health applications, including pilots addressing perinatal depression, depression following pregnancy loss, and mood disorders during perimenopause. This matters because medication isn’t always suitable or preferred in these life stages.

• Muse sleep & meditation headband: The Muse S is one of the more established head-worn devices with over 200 peer-reviewed studies investigating its effects on cognitive performance, anxiety, PTSD, and sleep. The device uses brain signals, heart rate and movement tracking to provide real-time feedback for meditation and sleep. It includes clinical grade sleep tracking too. A clinical trial specifically for menopausal insomnia is underway, evaluating the Muse S as a non-pharmacological alternative. In 2025, Muse users collectively tracked 56.5 million minutes of sleep, selling at $250 to consumers.

3. On the chest / torso: smart bras & perimenopause sensors

The chest and torso are emerging as another focus area for wearables - especially around the breast and upper chest where there are rich signal sources. Emerging directions focus on breast-focused sensing (smart bras and inserts) for heart, breathing, body composition and breast changes, as well as perimenopause as an under‑served but high‑impact use case. This category is still early. The challenge is that breast tissue moves and changes shape so signals can be easily distorted by motion and pressure. And, any product that claims early cancer detection faces the same evidentiary and regulatory bar as mammography or MRI. So far, there are no clear winners - which tells you how hard it is to get right.

In contrast, perimenopause sensors like Peri are already in the market, repurposing CGM‑style adhesive patches on the torso to track hot flashes, night sweats, and cardiometabolic load.

Overall, these devices are important because they represent a women-specific shift in wearables which has been largely invisible in mainstream wearables.

• Bloomer Tech smart bra: Bloomer Tech’s wearable integrates an electrocardiogram device with the goal of improving heart disease treatment and prevention. It collects data on heart function, lungs, hormones and metabolism to detect irregularities. The product is still in the testing phase.

• Petal smart bra insert: Petal has developed a bra insert which that tracks heart rate, HRV, breathing rate, menstrual cycle phase, and body composition using bio-impedance analysis (BIA). This uses electrical signals rather than optical sensors which are common to wrist wearables. Petal is in consumer waitlist phase as of early 2026 with a pre-order pricing of $199.

• IcosaMed smart bra: IncosaMed integrates ultrasound sensors into its wearable for early detection of breast cancer at home. Embedded, miniaturized ultrasound transducers safely create 3D images of breast tissue without the use of harmful radiation or uncomfortable compression. The technology is however still under development and has been demonstrated at the prototype level with few recent updates available.

Additional companies innovating in smart bras: In general, there have been several projects or companies pursuing the smart bra idea. Cyrcadia Health raised almost $5M and reached the stage of clinical trials but ultimately ceased operations. A team from MIT developed a smart sensor patch that can be attached to the bra to track interval cancers (tumors that appear between regular mammograms) but the project has so far remained at a prototype level. It seems that there is still a need for a strong player to bring the smart bra concept to market.

• Peri perimenopause tracker: Peri is positioned as the world’s first wearable designed specifically to monitor physiological signals associated with perimenopause symptoms. The adhesive sensor patch, worn on the torso below the bra line tracks temperature, heart rate, stress signals and movement to to identify patterns linked to hot flashes, night sweats, sleep disruption, and anxiety. The device syncs with a companion app that combines these signals with menstrual-cycle and lifestyle information to generate personalized insights and symptom tracking over time. Introduced at CES 2026, Peri launched with a retail price of $449, aiming to provide women and clinicians with objective longitudinal data on perimenopause, a life stage that is often under-recognized in clinical practice.

4. On the wrist & finger: rings & bracelets

This category is the most commercially mature, with multiple clinically-validated devices and significant user adoption.

There are now two groups competing: general-purpose rings (Oura, Samsung, Ultrahuman) and women-first devices (Evie, Ava, Bellabeat).

Those in the general category are quickly adding skin temperature sensors, cycle AI and women’s health integrations. Interestingly, overall smart ring shipments grew 49% in 2025, far outpacing the 6% increase in the segment of smartwatches.

Not all players are taking women’s health equally seriously. Some treat it as an add-on, while others, like Oura, are investing more heavily in women’s health features, research and partnerships. The rapid growth of women’s health features in wearables is also being driven by investor interest in the broader digital health and “human performance” category. The momentum is highlighted by the Oura decacorn fundraise in 2025, as well as WHOOP’s’ $575 million round just this month with players like Abbot and Mayo Clinic among investors.

Rings:

• Oura Ring, a leader in the ring segment, has sold 5.5 million rings since its 2015 launch - around half in the last year alone - and raised $900 million in October 2025 at an $11 billion valuation. While Oura started as a general wellness and sport company, in the last years it has been increasingly focusing on women, adding women’s health features like cycle tracking (the Oura Ring 4 uses nightly skin temperature to infer menstrual phase) and looking into perimenopause support (by doing a study and a report on perimenopause). Oura has partnered with a variety of women’s health companies like Clue, Natural Cycles, Mira and others to provide relevant cycle, fertility and hormonal tracking integrations. In February 2026 the company launched a women’s health-specific AI model within its Oura Advisor chatbot, trained on clinical research and individual biometric data. Women now represent 59% of Oura’s customer base, with young women (especially in their 20s and early 30s) as the fastest‑growing segment.

• Ultrahuman Ring includes menstrual cycle and fertility awareness features derived from overnight temperature trends, heart rate variability, and other physiological signals collected by the smart ring. Within the Ultrahuman app, these signals are analyzed using the Cycle & Ovulation feature to estimate cycle phases and potential ovulation timing, allowing users to track patterns over multiple cycles. This feature is powered through its acquisition of the women’s healthtech company viO HealthTech which took place in 2025. Ultrahuman positions its platform as a metabolic-health wearable ecosystem that integrates reproductive health signals with broader physiological monitoring. The company has published research based on thousands of cycles collected from ring users, examining factors such as stress, BMI, and activity levels in menstrual variability on a dataset of more than 4000 cycles. Their JADE AI connects ring biometrics with 120+ blood biomarkers, CGM glucose trends, and environmental data which is one of the most advanced and data-rich integration currently on the market in a consumer ring.

• Movano Evie Ring: the Evie Ring has been originally designed with a focus on women’s health and it is backed by Movano’s clinical technology, which achieved FDA 510(k) clearance for the pulse oximetry (SpO2 and pulse rate) features in its medical-grade EvieMED counterpart. The launch has not been without challenges. While the Evie Ring was long anticipated ahead of its original launch early in 2024, despite securing $1million in advance sales in its Black Friday pre-order sales alone, it was quickly and temporarily discontinued after negative customer feedback and lukewarm expert reviews. It was relaunched again in 2024 with a new design. At CES 2025, Movano unveiled EvieAI, a wearable-based virtual wellness assistant uniquely trained on over 100,000 medical journals. Expanding its ecosystem, Movano also recently updated the Evie app to include Apple Health integration, daily basal body temperature logging, and comprehensive 7- and 30-day trend graphs for its sleep metrics. At the date of publication, the ring appears to be out of stock on the company’s website.

Women’s health wrist wearables:

• Ava fertility tracking bracelet: Ava Fertility Tracker is a wrist-worn fertility-tracking wearable that has received clearance from FDA and has been CE-marked as a fertility-monitoring device. The bracelet is worn overnight to estimate and predict the fertile window. It continuously measures multiple physiological parameters associated with hormonal changes across the menstrual cycle, including resting pulse rate, skin temperature, heart-rate variability, breathing rate, and peripheral perfusion. Studies suggest 90% accuracy when validated against urinary luteinizing hormone testing. However, independent research indicates that additional validation in real-world (“free-living”) conditions is needed.

• Bellabeat Ivy bracelet: Bellabeat Ivy is a wearable wellness tracker designed with a jewelry-style form factor rather than a traditional sports wearable. The device monitors heart rate, activity, sleep patterns, and stress, and includes features for tracking menstrual cycles and reproductive health. The Ivy platform emphasizes holistic lifestyle insights, integrating wellness metrics with menstrual cycle information in the Bellabeat app. The device received recognition as a TIME Best Invention and targets users seeking health tracking in a discreet, fashion-oriented wearable format. It is being sold at $380.

• Clair Non-invasive wrist hormone monitor: Clair, a Stanford-born startup, generated significant attention with its 2026 launch announcement, outlining plans for a wrist wearable that aims to use 10 biosensors to estimate hormone levels in real timewithout blood draws or urine tests. The sensors (including skin temperature, resting heart rate, HRV, sleep architecture, breathing rate, electrodermal activity, and motion) are fed into a proprietary AI to infer levels of estrogen, progesterone, LH and FSH. Clair describes this as continuous hormone tracking, though some critics argue that term should be reserved for direct measurement rather than inferred signals. In early testing of 40 women and 127 cycles (5,000+ days of data), Clair reports 94.1% accuracy in cycle phase classification, with LH surge detection at 87% sensitivity and timing accuracy within 1.2 days. Shipping is planned for November 2026.

If validated in larger clinical studies, continuous hormone estimation could represent a new category of reproductive health monitoring beyond temperature-based cycle tracking, though the technology is still under development.

Big consumer watch & wristband players in women’s health:

• Apple’s approach to women’s health centres on cycle tracking. Its models estimate period timing and fertile windows based on historical cycle data. Newer Apple Watch models also add dual wrist temperature sensors and heart-rate monitoring for improved cycle and ovulation predictions when worn during sleep. Cycle deviation alerts can flag irregular, infrequent, or prolonged cycles that may signal underlying conditions. Early findings from the large-scale Apple & Harvard Women’s Health Study, the first study of its kind on lifestyle and demographic factors impact on menstrual cycle, showed that cycle deviations occurred in ~16% of participants, highlighting the potential of wearable data for large-scale reproductive health monitoring.

• WHOOP focuses on how hormonal changes impact recovery and performance. Its Hormonal Insights feature connects menstrual cycle phases with personalized recommendations for sleep, strain, and stress management, while also offering pregnancy tracking and symptom logging. A distinctive scientific contribution from WHOOP research is the “Cardiovascular Amplitude” metric, derived from analysis of more than 11,000 members and 45,000 cycles, which quantifies changes in HRV and resting heart rate across the menstrual cycle. The analysis found that 93% of participants showed predictable cardiovascular shifts between follicular and luteal phases. WHOOP has also expanded into biomarker testing with a women’s health blood test panel measuring 11 hormones and metabolic markers - including AMH, progesterone, and thyroid indicators - to complement wearable insights.

• Garmin integrates menstrual health insights across its smartwatch ecosystem via the Garmin Connect platform, which allows users to track cycle phases, symptoms, pregnancy, sleep, stress, and training performance. Garmin has increasingly positioned its wearables as tools for large-scale women’s health research. In 2025 the company announced a major collaboration with King’s College London to support the EMBRACE research program, a global study that will collect smartwatch and fitness-tracker data from up to 40,000 participants to better understand pregnancy and maternal health outcomes. Lately Garmin has integrated the FDA‑cleared Natural Cycles birth control app with select smartwatches so that overnight skin‑temperature data from the watch can be used to provide non‑hormonal fertility and contraception insights in the Natural Cycles app.

• Polar’s women’s health functionality focuses primarily on cycle awareness within athletic performance tracking, rather than clinical reproductive monitoring. Recent Polar watches feature nightly skin temperature tracking, which measures deviations from a user’s baseline during sleep and can reflect hormonal shifts associated with ovulation and the luteal phase. These signals feed into Polar’s Polar Elixir biosensing platform, which combines heart rate, HRV, temperature, and recovery metrics to provide personalized wellness insights. Through the Polar Flow app, users can log menstrual cycle information and interpret training readiness relative to hormonal phases, supporting a growing trend toward cycle-informed exercise and recovery optimization for female athletes.

• Withings integrates women’s health tracking across its hybrid smartwatch ecosystems. The platform combines manual logging with physiological signals from wearable sensors such as continuous temperature tracking, heart rate, respiratory rate, and sleep metrics, which can help identify hormonal patterns across the menstrual cycle. Flagship devices like ScanWatch 2 include the TempTech 24/7 module, enabling continuous body-temperature monitoring that can support retrospective ovulation confirmation and cycle insights when combined with historical cycle data. In 2025 Withings partnered with Clue, integrating Clue’s cycle-prediction algorithms with wearable data such as temperature, sleep, and stress metrics.

5. On the abdomen hips & lower back: period pain and bone health

Drug-free electrical pain management has strong clinical backing for period pain. A 2026 meta-analysis confirmed TENS can work as a standalone treatment when used at the right intensity. Every device in this segment is women-specific by design.

• Livia for period pain: Livia is a clip-on TENS device using patented SmartWave™ technology to block period pain signals before they reach the brain, backed by three double-blind, randomised clinical studies in primary dysmenorrhea. It holds FDA clearance, Health Canada approval, and CE marking. Livia gained meaningful post-market clinical support thanks to the recent meta-analysis evidence. It is currently the gold standard among consumer period pain TENS devices.

• Ovira (Noha) & also EVA are comparable TENS-based wearables for period pain, using clip-on form factors similar to Livia and addressing the period pain too. EVA extends this by also offering intra-vaginal electrical stimulation as an option, broadening its scope to pelvic floor engagement beyond surface-level pain blockade.

All three products position themselves ass drug-free period pain management alternatives. This is one of the few areas in women’s health weearables where there is strong clinical backing, a clear use case and products are already established and on the market.

• Osteoboost for bone health: Osteoboost Health’s vibration therapy is daily wearable, worn at the hips, designed for low bone density. It is a class II prescription wearable that delivers targeted vibration therapy to the hips and spine - areas most vulnerable to osteoporotic fractures. Osteoboost is positioned as the first FDA-cleared, non-drug treatment for women with osteopenia, a precursor to osteoporosis. Osteoboost recently secured $8million to scale its wearable.

6. On the pelvis: smart cups & pelvic floor devices

This category is entirely women-specific.. The clinical stakes are high: urinary incontinence affects one in three women, and endometriosis takes an average of 8 -10 years to diagnose. Both problems are driving serious investment in this category.

• Emm smart menstrual cup embeds ultra-thin biosensors that automatically track flow volume, daily flow rate, cup usage timing, and cycle regularity with no need for manual input. Data goes from sensors to the app via a charging case, not during wear. The company has specifically positioned Emm as a potential tool for earlier detection of endometriosis by providing objective, longitudinal flow data that could shorten the diagnostic conversation. UK launch is planned for 2026, with US market entry targeted for 2027.

• Perifit (and others) smart kegel trainers: Perifit’s insertable silicone device uses patented double-pressure sensor technology to distinguish faulty pelvic floor contractions from correct ones, connecting to a gamified smartphone app. CE-marked and clinically proven to improve pelvic floor strength and reduce urinary incontinence. The gamification model addresses the real barrier to pelvic floor training: not knowledge, but consistent follow-through.

• INNOVO Shorts for pelvic floor stimulation and urinary incontinence: INNOVO is a non-insertable alternative for pelvic floor treatment and so it is the most clinically significant device in the pelvic floor category. It is wearable shorts with built-in :electrodes delivering eletrical stimulation equivalent to kegel, with no insertion required. It received FDA De Novo clearance in November 2018 and OTC clearance on 5 February 2020, making it the first transcutaneous electrical stimulation continence device cleared for OTC use in the US. In the pivotal multi-centre RCT, 87% of users were considered dry or near-dry after 12 weeks, establishing the device’s clinical credibility.

7. Pregnancy & fetal monitoring and breastfeeding

During pregnancy, the wearable stack becomes more complex and expands significantly: since devices must track both maternal and fetal signals, manage gestational hypertension risk, and support remote prenatal care.

With nearly two in three pregnancies now qualifying as high-risk, demand is growing for clinically-approved, at-home fetal monitoring. As a result, the devices in this segment are among the most rigorously regulated wearables on the market.

Postpartum, wearable breastpumps have become one of the most widely adopted women’s health devices.

• Bloomlife remote maternal & fetal monitoring: Bloomlife has developed MFM-Pro, a remote monitoring wearable designed to support clinical care for high-risk pregnancies. The system uses a wearable abdominal ECG patch that measures fetal heart rate (FHR) and maternal heart rate (MHR) during late pregnancy and transmits data to a connected digital platform used by clinicians for remote assessment. The device received FDA 510(k) clearance for fetal and maternal heart rate monitoring from 32 weeks of gestation onward. Bloomlife integrates with hospital telehealth workflows for remote pregnancy monitoring. Clinical evaluations, including studies conducted within European research programs, have compared the system’s measurements with standard cardiotocography (CTG) and demonstrated feasibility for home-based fetal monitoring.

• INVU by Nuvo home non-stress testing: named a TIME Best Invention 2024, the INVU wearable abdominal band contains 12 sensors using ECG and acoustic (phonocardiographic) signals to measure fetal heart rate, maternal heart rate, and uterine activity remotely. FDA- and CE-cleared and prescription-initiated for high-risk pregnancies, currently used by healthcare providers and research institutions in the USA and Israel. A clinical study demonstrated that INVU’s uterine activity detection achieved 89.8% sensitivity, outperforming standard tocodynamometry (TOCO) in detecting uterine contractions when benchmarked against intrauterine pressure catheter (IUPC) measurements. This all supports INVU’s use as a telehealth tool for managing pregnancies that require frequent monitoring.

• Molecular wearable for pregnancy risk monitoring by MoleSense: MoleSense is a Swiss medtech startup developing a non-invasive molecular wearable patch for pregnancy monitoring, focused on detecting hormonal and inflammatory biomarkers through sweat rather than measuring only vital signs. The skin-worn device uses microfluidics and DNA-based biosensors to analyze sweat chemistry over time, with the goal of identifying risks such as infection, inflammation, and preterm birth earlier than conventional snapshot blood tests. Unlike fetal-monitoring wearables that track heart rate or contractions, MoleSense is positioning itself as a next-generation biochemical monitoring platform for maternal health, aimed at high-risk pregnancies and postpartum care. Early feasibility work has been conducted with obstetric specialists in Lausanne, and the company states that the next phase is clinical validation of biomarker accuracy and real-world utility before regulatory submissions.

• Willow (and others) wearable breast pumps such as Willow: In the postpartum period, wearable breast pumps represent one of the most adopted categories of women’s health wearables. The leading products in this category are Willow pumps, produced by Willow Innovations (including consolidation with Elvie Pump, whose assets were acquired by Willow). These devices combine quiet electric pumping systems, in-bra form factors, and mobile-app connectivity to allow discreet pumping during daily activities. The wearable breast pump market has expanded rapidly in recent years, with estimates suggesting global revenues of over $500 million in 2023 and continued growth driven by increasing demand for portable, work-compatible lactation technology. While products differ in design and pumping mechanisms, both brands aim to improve convenience and flexibility for breastfeeding parents during the postpartum period.

8. Menopause-related hot flash & thermoregulation wearables

This category is shifting from tracking symptoms to actively treating them. The wrist is used as one of the main sites for cooling, targeting women who cannot or do not want to use hormone therapy. Most devices in this segment do not aim to change core body temperature instead, they stimulate thermoreceptors at the wrist or use phase‑change materials to alter thermal perception and blunt vasomotor symptoms, with early clinical studies suggesting meaningful reductions in hot‑flash severity and interference with daily life. Most devices don’t try to change core body temperature. Instead, they cool the wrist to trick the body’s temperature perception, helping reduce hot flashes. This is particularly relevant for women who can’t or don’t want to use hormone therapy. Early studies suggest these approaches can reduce severity and daily disruption of symptoms.

• Embr thermal wristband for hot flash relief: the Embr Wave 2 delivers short bursts of cooling or warmingto the inner wrist using thermoelectric elements. Instead of changing full-body temperature, the device stimulates thermoreceptors in the skin, triggering the brain’s perception of cooling or warming to relieve hot flashes and night sweats. Users can activate sessions manually or through a companion app, to help interrupt the onset of vasomotor symptoms. Early studies suggest that wrist-based thermal interventions can significantly reduce hot flash severity and frequency by altering the body’s thermoregulatory response. The device is widely available in North America and Europe and retails for about $299.

• KÜLKUF clinical wrist cooling device: the KÜLKUF wristband is a thermoelectric cooling wearable investigated in clinical studies for the treatment of vasomotor symptoms such as hot flashes. The device delivers localized cooling to the wrist to influence thermoregulatory perception. Pilot studies using self-reported outcomes suggest a 46% reduction in severe hot flashes and an 18% reduction in total daily episodes, suggesting that targeted peripheral cooling can meaningfully reduce vasomotor symptom burden. The device remains in limited distribution and research settings for now.The wristband is priced as $199.

• MyCelsius cooling wearable bracelet: the MyCelsius bracelet is a simpler, non-electronic approach. It is a non-invasive cooling device that usesphase-change cooling materials to absorb heat from the skin and deliver a prolonged cooling sensation when worn on the wrist. The device does not require charging or electronic control. With pricing of £229 in the UK market, MyCelsius illustrates a parallel segment of menopause technology focused on low-tech thermal regulation rather than biometric sensing.

Conclusion

There are many more women’s health wearables than most people assume - and that’s one of the key takeaways from this report.

Across categories we are seeing that passive and continuous sensing is replacing manual logging. Parameters like skin temperature, HRV, and resting heart rate are used as proxies for hormonal state rather than just fitness metrics. AI now sits on top of those data streams, with platforms like Oura, WHOOP, Ultrahuman and Apple training models on population‑scale cycle data to personalise insights. And general‑purpose ecosystems such as Apple Watch, Polar, WHOOP or Garmin are retrofitting women‑specific features via temperature sensors and cycle‑aware algorithms. Femtech‑first devices like Evie Ring, Ava, and Bellabeat go deeper on reproductive questions but serve smaller user bases.

All of this sits against a backdrop where the “imperfect wearable” is often competing with an “imperfect system.” These products are not diagnostic tools, but they create dense, longitudinal traces of symptoms and physiology that no annual appointment can match, especially for conditions like PCOS, endometriosis, and perimenopause, where symptoms are cyclical, variable, and often dismissed.

In this context, the question is whether a device adds information the healthcare system systematically misses. In many cases, our conclusion in this report is that the answer is yes. Regulatory clearance can definitely be a competitive advantage - but it is often misunderstood.Many times devices are being labeled as ‘approved by FDA’ without a context of what is the designation of the approval and what are the caveats. For example, screening features (like hypertension alerts) still require clinical follow-up and won’t catch every case.

At the same time, when the safety profile is solid, a wellness‑class hot‑flash or HRV sensor can still be clinically useful even if it never crosses into drug‑device territory.

As wearables improve, more responsibility shifts to the user. Data is generated outside of the clinic, interpretation often sits with the individual and decisions are increasingly influenced before a doctor is involved. That’s both an opportunity and a risk.

Wearables aren’t replacing healthcare - but they do change where insight is surfaced and where control sits. For women, long overlooked and dismissed by the healthcare system the benefits are already clear.

This article was written for FutureFemHealth by women’s health strategist Anastasiya Markvarde.

A UK-based pregnancy and postpartum wellbeing app is launching a new feature designed to support women following miscarriage and pregnancy loss, highlighting ongoing gaps in both NHS care pathways and digital health platforms.

Carea has introduced a “Healing After Loss” mode within its app, offering users access to expert-led guidance, mental health tools and peer support following pregnancy loss - an area where many women report limited support and unclear clinical pathways.

The launch comes as one in four pregnancies in the UK ends in loss, yet support remains inconsistent. Women experiencing early signs of miscarriage are often advised to “wait and see”, with many describing a lack of clear guidance on next steps and limited access to timely mental health support.

Research suggests the psychological impact can be significant, with around 29% of women meeting the criteria for post-traumatic stress one month after early pregnancy loss, alongside elevated rates of anxiety and depression.

Carea’s new feature combines evidence-based information with tools such as breathwork, journaling prompts, affirmations and guided meditations, alongside access to a community of women with shared experiences. The feature is available free of charge within the app and can be accessed by both new and existing users.

The product was developed by founder Anastasia Shubareva-Epshtein following her own experience of miscarriage, which she said exposed a gap in how both healthcare systems and pregnancy apps respond to loss.

“We have heard from so many women that they feel like it is somehow their fault or they are feeling guilty or ashamed when they experience a pregnancy loss,” she said.

“I experienced first-hand how hard many pregnancy apps make it to report a loss and how insensitive and triggering the whole experience can be. You’re left feeling excluded at the very moment you needed support most.”

Designed sensitivity

The feature also addresses shortcomings in existing pregnancy apps, where users can face distressing experiences after reporting a loss, including continued updates on foetal development or inappropriate targeted content.

The launch sits within a broader shift in attention towards miscarriage care in the UK. Health Secretary Wes Streeting has recently acknowledged that support for pregnancy loss has “traditionally been lacking”, while Scotland published the UK’s first miscarriage patient charter earlier this year.

Despite this growing policy focus, early pregnancy loss remains under-recognised within formal systems. Losses before 24 weeks are not registered in the same way as stillbirths, contributing to what many describe as a lack of acknowledgement and support.

Carea said the new feature is designed to be accessible regardless of when the loss occurred and does not require users to share sensitive personal details to access support.

The company positions the feature as part of a wider effort to support women across the full motherhood journey - from fertility and loss through to pregnancy and postpartum - while addressing what it sees as a persistent gap between clinical care and lived experience.

Carea was launched in April 2025 and has been downloaded 10,000+ times to date.

A diagnostic test for endometriosis and adenomyosis has received CE marking, allowing it to be commercially deployed across the European Union.

The ENDOSURE Test, developed by US-based ENDOSURE Inc., is a non-invasive diagnostic designed to detect endometriosis in around 30 minutes.

The company says the test can be used across all stages of disease and age groups, including adolescents and postmenopausal women. Existing tests, such as Ziwig’s Endotest - which received the CE mark in 2022 - are currently indicated for those aged 18 to 43 years old.

“For the first time, a non-invasive test has been approved for use in adolescents, where the disease often begins,” said Dr. Mark Noar, co-founder and inventor of the ENDOSURE Test.

“This opens unprecedented opportunities for early suppressive therapy that could conceivably prevent progression to adult end-stage disease within 5 to 10 years.”

Endometriosis affects an estimated one in ten women globally and is associated with symptoms including chronic pelvic pain, heavy bleeding and infertility. Despite its prevalence, diagnosis remains a significant challenge, with delays often stretching for years due to reliance on imaging, clinical assessment and, in some cases, surgical confirmation. Laparoscopy is considered the gold standard for diagnosis, but as it requires surgical intervention, it is often avoided until symptoms become severe.

ENDOSURE could be used earlier in the care pathway as a first-line diagnostic, with potential to reduce delays and support ongoing disease management. The company also suggests the test could support ongoing disease management by helping clinicians assess treatment response and detect recurrence.

The CE mark follows approvals in a number of other markets, including the UK, Canada and parts of the Middle East, and enables the company to begin commercial rollout across Europe.

“This significant milestone opens access to one of the world’s largest healthcare markets,” added Carlos Babini, chief executive of ENDOSURE Inc.

“Long diagnostic delays for women are largely driven by limitations in current testing, including cost, access, accuracy, ease of use, and slow results.”

The company plans a rapid launch across the region, targeting healthcare providers and hospitals, though adoption will depend on clinical validation, reimbursement and integration into existing care pathways.

The development comes amid growing interest in non-invasive diagnostics for endometriosis, as companies seek to address one of the most persistent gaps in women’s health — early and accurate diagnosis of a condition that remains widely under-recognised and under-treated.

An AI-based system that autonomously selects and isolates sperm cells has been used in an IVF cycle resulting in a confirmed pregnancy, marking a first-in-human milestone for fully automated sperm selection.

Developed by Israeli medtech company BAIBYS, the system combines artificial intelligence with robotic micromanipulation to both identify and physically isolate individual sperm cells for use in intracytoplasmic sperm injection (ICSI). The procedure was carried out in Paris in December 2025, involving a 37-year-old patient, with the pregnancy now confirmed beyond the first trimester.

While AI tools are already used in IVF to support sperm and embryo selection, these systems typically guide embryologists rather than replace them.

The physical selection and handling of cells remains a manual process, which relies on specialist skill and is therefore subject to variation between operators. In this case, the BAIBYS system performs both steps autonomously - selecting sperm cells based on morphology and motility, and physically isolating them without human intervention.

“This result validates the core premise behind BAIBYS: that one of the most consequential decisions in an ART cycle, selecting which sperm cells will be used to create embryos, should not depend on subjective visual assessment,” said Yaron Silberman, co-chief executive of BAIBYS.

“This pregnancy demonstrates that the approach works in a live clinical setting.”

Why sperm selection is key in IVF

Sperm selection remains one of the more technically demanding steps within IVF. According to the World Health Organization, more than 96% of sperm cells in a typical sample are considered abnormal. Some techniques such as high-magnification selection can improve identification of structurally normal cells but these approaches are time-intensive, require significant expertise and are not widely used in routine clinical practice.

BAIBYS is attempting to address that gap by combining high-magnification imaging with automated classification and robotic handling. The system evaluates sperm cells based on both motility and fine morphology, in line with WHO criteria, rather than motility alone, which is the basis for many existing software tools. In a validation study, the company reports 95% agreement with expert classifications in identifying morphologically normal sperm cells.

Its primary point of differentiation, however, is not just analysis but execution. Using robotic micro-manipulation, the system physically picks up selected sperm cells and isolates them into a separate droplet, ready for use in ICSI. Existing AI tools may recommend cells but still require an embryologist to perform this step manually.

In practice, clinicians load a disposable cartridge containing the sperm sample, select the number of cells required, and initiate the process. The system then runs automatically until sufficient cells have been isolated.

“We built BAIBYS to make high-magnification sperm selection accessible across fertility clinics,” said Gal Golov, co-chief executive and co-founder of the company.

“This milestone confirms that autonomous robotic sperm selection can deliver clinical results while addressing the growing shortage of skilled laboratory professionals and the global decline in sperm quantity and quality.”

The company holds CE mark certification and ISO 13485 accreditation, and has received funding support from the Israel Innovation Authority, alongside backing from healthcare-focused venture capital firm ACP HealthTech.

Although the technology targets sperm, it sits within the IVF process where treatment burden, cost and outcomes are primarily experienced by women. Any change to how embryos are created has downstream implications for how many treatment cycles a patient may need to undergo.

The result is currently based on a single case, and no comparative clinical data has yet been published on whether the system improves outcomes such as fertilisation rates, embryo quality or live birth rates.

A new survey of 1,000 women suggests that gaps in reproductive health knowledge, diagnosis and care have remained largely unchanged across generations, despite growing attention on women’s health.

The study, commissioned by reproductive health platform myStoria, found that more than half of respondents had been told their symptoms were “normal” by a healthcare provider before later discovering they were not. Over 60% reported needing to see multiple providers to get a meaningful answer.

Most notably, the data showed little variation across age groups. Women in their twenties, thirties and fifties reported near-identical experiences - from delayed understanding of symptoms to feeling unprepared by school-based sex education.

More than half of respondents said sex education had not prepared them for adult reproductive health, while nearly 40% delayed seeking care because they were unsure whether their symptoms were serious enough.

Together, the findings point to a system that is not failing at a single point of care, but across the entire journey - from education and early awareness through to diagnosis and treatment. Researchers describe five interconnected gaps (in knowledge, dismissal, generation, navigation, and tools) that compound over a lifetime of reproductive health decisions.

“This is not a story about individual providers failing individual patients,” said Jessica Chalk, founder and chief executive of myStoria. “It is a story about a system that was never designed to prepare us for our own bodies.”

The survey also highlights the extent of the “invisible labour” involved in navigating reproductive health. Nearly one-third of respondents reported spending one to three hours per week researching, booking appointments and coordinating care.

While awareness of women’s health issues has increased in recent years, the data suggests that this has not yet translated into meaningful improvements in how women experience care.

Knowledge can also be traced back to the earliest days - with 56% of respondents saying that school-based sex education did not prepare them for adult reproductive health, and only 22.8% agreed that it did.

The report concludes that information and knowledge could make a meaningful difference to health experiences. When respondents were asked what single thing would have made the biggest difference in their reproductive health journey, 41.8% said understanding their symptoms earlier - nearly twice as often as the next most common answer. A further 24.2% said knowing what questions to ask and how to advocate for themselves. Together, these two answers account for 65.7% of all respondents.

A new biotech company is aiming to tackle a largely unaddressed driver of cardiovascular risk in women, with a drug and diagnostic platform designed specifically for those experiencing declining estrogen levels post menopause.

Septagen Pharmaceuticals, a spinout from Vanderbilt University in the US, is developing a precision medicine approach to what it describes as thromboinflammatory cardiovascular disease - a mechanism linked to increased platelet activity that is not addressed by current standard treatments.

Cardiovascular disease remains the leading cause of death in women, yet treatment approaches are largely the same as those used in men, typically relying on statins, blood pressure medication and aspirin.

“There are more than 55 million postmenopausal women in the United States alone, and no approved therapies specifically target the thromboinflammatory risk driving their cardiovascular events,” said Chief Executive Officer Malcolm Bohm, MD, PhD, a physician-executive with over 25 years of drug development experience and multiple successful exits.

“Septagen was built to change that - by bringing precision medicine to women’s heart disease in a way that has never been done before.”

The company was co-founded with Chief Scientific Officer Heidi E. Hamm, PhD, a globally recognized leader in GPCR biology and cardiovascular signaling whose laboratory generated the foundational science behind the company’s approach.

Towards precision medicine

Septagen’s approach combines a blood-based diagnostic with a targeted therapy. Patients would first take a test designed to identify elevated platelet-driven risk. Those who test positive would then be treated with a once-daily oral drug aimed at reducing that specific mechanism, alongside existing therapies.

The model reflects a broader shift towards precision medicine, where treatments are matched to underlying biological drivers rather than applied uniformly across patient groups.

“Today, a postmenopausal woman who sees her cardiologist gets the same tools as everyone else,” added Bohm. “None of those address what is happening at the platelet level.”

While the PAR4 receptor targeted by Septagen’s drug has been studied previously, the company’s approach is based on newly established links between estrogen decline, changes in bone marrow biology, and increased platelet activity.

“The pieces existed separately,” Bohm said. “Our contribution is connecting them into a coherent, testable and treatable mechanism.”

The company is currently in preclinical development and is targeting submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration within 18 to 24 months. First human trials are expected to begin between 2027 and 2028, likely in partnership with a larger pharmaceutical company.

The launch comes amid growing attention to gaps in women’s cardiovascular care, particularly in the years following menopause, when risk increases but underlying mechanisms remain poorly understood and often untreated.

“Women’s heart disease is not just a smaller version of men’s—it is fundamentally different,” added Bohm. “We now have the science, the tools, and the timing to build a company specifically designed for that reality.”

Welcome to the first FutureFemHealth Pro - a new paid layer where I’ll be sharing more analysis, insights and opinions on the future of women’s health and Femtech.

In its first week, FutureFemHealth Pro made Substack’s top 10 rising sellers list on Substack (appearing at no.9!) and our group of founding members include CEOs, founders, advocates, investors, policy leads and more.

This is the first piece from FutureFemHealth Pro.

Q1 in review

In Q1, FutureFemHealth tracked $1.24 billion being invested into women’s health across 33 deals.

But that’s a slightly misleading number, since nearly half of it comes from a single deal (WHOOP’s $575 million) - a company that isn’t even positioned as women’s health. So, if we strip that out the figure stands at $665 million - quite different.

What’s actually happening beneath the surface and how should we be thinking about the WHOOP raise?

In this first FutureFemHealth Pro piece, I break down five key takeaways from Q1 and what they mean for where the market goes next.

The full analysis, including all five signals and what they mean for the rest of 2026 is available to FutureFemHealth Pro members.

📊 As a Pro member, you can also download my full spreadsheet of every deal I tracked along with my notes on each*:

Read more

Fertility technology company FertilAI has received CE marking under the EU Medical Device Regulation (MDR) for its AI-driven clinical decision support tools, marking what the company says is the first regulatory clearance for a predictive AI platform designed to optimise timing decisions during active fertility treatment cycles.

The approval covers FertilAI’s Fertilane platform, which integrates with electronic medical record (EMR) systems and provides clinicians with real-time, data-driven insights during IVF and other fertility treatments.

“Our goal is to accelerate and ease the patients’ fertility treatment journey to parenthood, no matter the path taken,” said Rohi Hourvitz, chief executive officer of FertilAI.

“Achieving the CE mark under the EU MDR validates our technologies’ ability to support more effective clinical decision making and simultaneously streamline clinic operations, all while increasing patient access to services without growing clinic overhead.”

AI targeting a critical decision point in fertility care

The newly cleared platform focuses on one of the most complex and variable aspects of fertility treatment: timing.

By analysing data from more than 100,000 treatment cycles, FertilAI’s algorithms are designed to predict ovulation and estimate the number of mature oocytes that can be retrieved at different trigger points - helping clinicians determine the optimal moment for intervention.

According to the company, this allows physicians to make more precise decisions during active treatment cycles, while also supporting clinic operations.

“To our knowledge, this is the world’s first CE-marked predictive AI-based fertility platform specifically designed to support the physician’s clinical timing decisions during active treatment cycles,” the company said in a statement.

Two algorithms targeting IVF and natural cycles

The CE mark covers two core tools within the Fertilane platform:

• StimAI (Class IIa) predicts the expected number of mature oocytes retrieved based on different trigger timings, supporting IVF decision-making and enabling clinics to better manage laboratory workloads

• OvuPredict (Class I) forecasts natural cycle ovulation up to six days in advance, which - based on published research in Nature Scientific Reports - may improve timing for intrauterine insemination (IUI) and frozen embryo transfer (FET), and reduce the need for intensive patient monitoring

Together, the tools are designed to support more personalised treatment while helping clinics manage daily scheduling and resource allocation.

Addressing access and capacity challenges

The approval comes as fertility services face rising demand globally, alongside workforce constraints and increasing treatment costs.

Rohi Hourvitz added that the platform could play a role in addressing capacity challenges in the sector.

“With the global rise in infertility and a worldwide shortage of physicians driving higher costs and longer wait times, expanding access to care is absolutely vital,” he said.

“Having a system that enables clinic scalability while actively improving clinical benefits and the patient experience is a pivotal step forward in addressing this growing challenge.”

FertilAI said the Fertilane platform is designed as a seamless SaaS solution that integrates directly into existing EMR systems, allowing clinicians to access AI-driven insights within their current workflows.

The company added that its technologies have been validated through multiple published studies in peer-reviewed journals, including Fertility and Sterility, Reproductive BioMedicine Online, and Nature Scientific Reports, with further randomised controlled trials ongoing.

The CE mark places FertilAI among a growing cohort of companies seeking to apply artificial intelligence to fertility treatment, an area characterised by high variability in outcomes and significant operational complexity.

Osteoboost Health has raised $8 million in new funding to expand access to its FDA-cleared prescription wearable designed to treat low bone density in postmenopausal women, as interest grows in non-drug interventions for age-related conditions.

The round was led by Ambit Health Ventures, with participation from Emmeline Ventures, Disrupt Health Impact Fund, Esplanade Ventures and Portfolia. The funding will be used to scale manufacturing, expand clinical research and grow commercial adoption.

The company’s flagship device, Osteoboost, is a class II prescription wearable that delivers targeted vibration therapy to the hips and spine - areas most vulnerable to osteoporotic fractures. It is positioned as the first FDA-cleared, non-drug treatment for women with osteopenia, a precursor to osteoporosis.

More than 2,500 physicians have prescribed the device to date, including clinicians at over 30 academic medical centres.

Addressing a gap in early intervention

Osteoboost is targeting a large and growing patient population. Nearly 10 million Americans are living with osteoporosis, while a further 44 million have low bone density. Yet treatment options for early-stage bone loss remain limited, particularly for women entering menopause, when bone density declines more rapidly.

“The cost of osteoporosis to society is enormous, but this is not a condition that begins at diagnosis. It develops silently over many years,” said Laura Yecies, chief executive officer of Osteoboost Health.

“That’s why earlier intervention and prevention are so critical, especially for women entering menopause—when bone loss is known to accelerate. This funding advances Osteoboost’s vision of building a complete bone health solution and changing the trajectory of bone health for millions.”

The device is worn around the hips and sacrum and delivers low-magnitude vibration therapy. Its development was inspired by NASA-funded research, and clinical validation comes from a double-blinded trial at the University of Nebraska Medical Center, which found it slowed bone density loss by 85% in the spine and 55% in the hips among patients using the device regularly over 12 months.

Investor focus on under-addressed women’s health needs

The funding comes amid broader attention to gaps in women’s health investment, particularly beyond reproductive and maternal care.

“At Emmeline, we invest in companies tackling the biggest unmet needs in women’s health,” said Azin Radsan van Alebeek, co-founder and general partner at Emmeline Ventures.

“Half of women over 50 will experience a fracture due to bone loss, yet osteoporosis remains dramatically underdiagnosed and undertreated. Laura and the Osteoboost team are bringing much-needed innovation to bone health, and we’re excited to support their mission.”

Despite the scale of need, women’s health continues to receive a relatively small share of private healthcare capital. A January 2026 report from the World Economic Forum found the sector accounts for just 6% of investment, with the majority concentrated in areas such as reproductive health and oncology.

At the same time, demographic trends are expected to increase demand for solutions targeting ageing populations. The World Health Organization projects that by 2030, one in six people globally will be aged 60 or older.

Clinical demand for non-drug options

Clinicians say the device addresses a longstanding gap in treatment for patients diagnosed with osteopenia, where pharmaceutical options are limited.

“For years, when a patient with osteopenia asked what they could do beyond calcium, vitamin D, and exercise, we didn’t have much to offer,” said David B. Karpf, an endocrinologist at Stanford University School of Medicine.

“Many of the women I treat are younger peri- and post-menopausal women who have osteopenia, and want to do everything they can to prevent developing osteoporosis, in order to stay strong enough to travel, exercise, and lift their grandchildren. But there are no approved drug therapies for osteopenia. This gap between diagnosis and drug therapy has been frustrating. The availability of the FDA-approved Osteoboost device provides a clinically supported, non-drug option that allows us to intervene earlier.”

The company has also expanded into digital services through Wellen by Osteoboost, an online training platform developed by physical therapists. In a study of 680 participants, users improved lower-body strength by 22.8% after completing an 18-session programme, with nearly 80% moving from elevated to average or above-average fall risk.

Early users have also pointed to the appeal of a non-pharmaceutical approach.

“Osteoboost appealed to me on so many levels,” said Esther Dyson, an Osteoboost user and early investor.

“As someone who has trained to go into space but has not actually gone - yet! - I knew about the original NASA research. I also have low bone density and a cracked (but not broken) femur from a fall, so I’m excited to see an alternative to the standard pharmaceutical approach.”

Regulatory and commercial traction

Osteoboost was designated a Breakthrough Device by the U.S. Food and Drug Administration in 2024 and later cleared through the De Novo pathway. The device began shipping in May 2025 and was named to TIME’s list of Best Inventions the same year.

The company said the new funding will support further expansion as it looks to position the device as part of a broader, preventative approach to bone health - particularly for women at risk of osteoporosis.

The UK government has announced a £1.5 million femtech challenge fund as part of its refreshed Women’s Health Strategy, alongside wider reforms aimed at tackling long waiting lists, improving pain management, and embedding women’s voices at the centre of NHS care.

Framing the need for reform, Health Secretary Wes Streeting said the NHS is a system that “too often gaslights women, treating their pain as an inconvenience and their symptoms as an overreaction,” adding: “women’s voices must be central to delivering effective, respectful and empathetic care.”

Published today, the strategy sets out a system-wide reset for women’s health services - focused on addressing entrenched cultural and structural failures in how women are listened to and treated.

Femtech funding and innovation measures

The headline measure in innovation is a modest £1.5 million FemTech challenge fund, intended to support adoption of technologies targeting unmet need in women’s health. This grant-based awards will encourage community service models addressing health inequalities. Examples will be evaluated as part of the programme, helping FemTech developers generate the evidence needed to spread their products across the NHS.

This sits alongside plans for a new accelerator for female founders, delivered through the National Institute for Health and Care Research (NIHR), offering funding, mentoring and commercial support for innovations aligned with NHS priorities.

The strategy also outlines a new NIHR R&D Innovation Catalyst to support high-priority innovations across development stages

There are also efforts to improve women’s participation in clinical trials, including integration with the NHS App. Notably there is also a requirement that publicly funded research must now account for sex-based differences in order to be funded.

The strategy also commits to trialling wearable technologies for women in areas of deprivation - working with innovators and providing devices for free in areas where health need and deprivation are highest. An initial focus will be on the detection and monitoring of cardiovascular disease.

A new collaboration will also launch with the Indian Department of Biotechnology on FemTech Research and Innovation.

Listening to women - and acting on it

While innovation features in the strategy, its core focus is on culture and accountability.

A key proposal is a new trial linking patient feedback to provider funding, where women will be asked whether services should receive full payment based on their experience. The aim is to ensure providers are held accountable for listening to women.

Additional measures include:

• Rolling out patient-reported outcome and experience measures (PROMs and PREMs)

• Establishing a Women’s Voices Partnership to inform policy

• Introducing new standards to ensure women are offered appropriate pain relief during procedures

The strategy highlights evidence that women are less likely to receive adequate pain treatment and more likely to have their symptoms dismissed.

Cutting waiting lists and improving access

Reducing delays in care - particularly in gynaecology - is another central pillar.

Women face long waits for diagnosis and treatment, with average gynaecology waiting times still standing at more than 565,000 and conditions such as endometriosis taking nearly a decade to diagnose.

To address this, the strategy proposes:

• A single point of access for gynaecology referrals

• Redesigned pathways for conditions including heavy periods, menopause and urogynaecology

• Expansion of community-based women’s health hubs

• Greater use of digital and online services to streamline care

The reforms aim to reduce repeated appointments and delays, and ensure women are directed to the right specialist more quickly.

Wider reforms across care and prevention

The strategy also includes a range of additional measures, including:

• A £1 million programme to improve menstrual health education

• Expanded access to contraception and abortion services

• New support for fertility services and pregnancy loss

• Integration of menopause support into routine NHS Health Checks

NHS England’s clinical director for women’s health, Dr Sue Mann, said:

“Too many women are still dismissed for serious symptoms that impact on every part of their lives.”

The first Women’s Health Strategy for England was published by the Department of Health and Social Care in 2022. The ten-year strategy followed a call for evidence in 2021 and introduced new measures such as the launch of women’s health hubs and the country’s first women’s health ambassador, Dame Lesley Regan.

🌟 In this week’s briefing:

• ⛹🏽‍♀️ Muse Capital launches Optima, bringing its women’s health portfolio directly into elite sport.

• 🏆 Proseek Bio raises $1.5m to commercialise its ovarian cancer detection test.

• 💰 Eka Ventures closes €91.5 million Fund II to back UK startups focusing on health, wellbeing and sustainability.

• 🔥 Protocole emerges from stealth and raises $6m to build clinical-grade peptide platform

Share your news: anna@futurefemhealth.com

But first….

Last week I introduced FutureFemHealth Pro - a new paid layer focused on deeper analysis on where women’s health is going.

I’ve been so pleased with the response - FutureFemHealth Pro even made it into Substack’s global ‘top 10 rising publications in Health and Wellness’!

But more importantly for me, a group of founder, investors, operators and leaders across the space have now joined FutureFemHealth Pro - spanning everything from diagnostics and digital health to non-profits and global health organisations.

I’ll send the first Pro piece later this week, where I’ll be breaking down the key signals from Q1 - what the funding data, company activity and broader market shifts are actually telling us about where the sector is heading, including a downloadable spreadsheet of all the deals including my notes on each.

Looking ahead, Pro is where I’ll now be sharing:

• deeper dives into specific areas (like PCOS)

• more context and analysis behind the headlines

• and the thinking that doesn’t fit into a weekly briefing

This weekly newsletter will continue as normal - but this is the direction FutureFemHealth is evolving in.

If you’d like to go deeper, you can join FutureFemHealth Pro here and receive the first piece later this week:

Join FutureFemHealth Pro

*P.S I know a few people had issues with their bank processing the payment for FFH Pro, do get in touch at anna@futurefemhealth.com and I can help you resolve this!

💰 Capital flows: where are investors placing bets?

📌 AUSTRALIA: Proseek Bio raises $1.5m to commercialise its ovarian cancer detection test. With 80% of surgeries for suspected ovarian cancer coming back benign, Proseek Bio says better diagnostics are urgently needed. Its test aims to support earlier and more precise clinical decision-making, while improving referral pathways and cutting unnecessary surgery. The OC-Triage identifies specific glycoproteins that indicate a future likelihood of ovarian cancer. The company says there are future applications beyond ovarian cancer in endometriosis triage and more. This seed round will fund the next stage of development as Proseek moves towards clinical lab deployment and validation. Funding for this round came from Edale Capital, Scale Investors, AngelLoop, AusHealth and others. (Continue reading: Women’s Agenda)

📌 US: Wavelet Medical raises $7m in seed funding to commercialise fetal brain monitoring technology. Fetal monitoring during labour still relies on heart rate - an indirect signal that can be inconclusive and lead to both missed distress and unnecessary C-sections. Wavelet is developing what it describes as the first non-invasive system to measure fetal brain activity directly, using AI to reconstruct EEG signals through the abdomen during labour. This funding came from venture studio Aegis Ventures, which is partnering with the company to help bring the technology into clinical use, bridging the gap between deep tech and real-wordl deployment. (Continue reading: Fierce Healthcare)

📌 US: Incyclix Bio raises $5m Series B extension to advance cancer drug trial. Treatment-resistant cancers remain a major challenge, particularly in breast and ovarian cancer where patients can stop responding to existing therapies over time. Incyclix is developing a new drug designed to target these resistance pathways, with its lead programme currently in early-stage clinical trials. This additional funding, led by Hatteras Venture Partners, will support the next phase of development as the company works toward further clinical validation. (Continue reading: GlobeNewswire)

📌 UK: Eka Ventures closes €91.5 million Fund II to back UK startups focusing on health, wellbeing and sustainability. In the last year, Eka Ventures has backed women’s health and wellbeing startups Hesta Health, Cyclana Bio and DITTO daily from this fund. According to Eka this raise establishes it as the UK’s largest early-stage impact VC, where it invests in companies that deliver both commercial and societal benefits in health, wellbeing and sustainability. The oversubscribed fund has been backed by leading LPs, including British Business Bank, Better Society Capital, Guy’s & St Thomas’ Foundation, The Health Foundation, WRAP, Esmée Fairbairn Foundation, John Ellerman Foundation, and The Vivensa Foundation. (Continue reading: EU-startups)

📌 US: Protocole emerges from stealth and raises $6m to build clinical-grade peptide platform. There’s early signs of women’s health companies expanding into the emerging (and somewhat controversial) peptide space. Peptides - small proteins used in areas like metabolism, recovery and longevity (including GLP-1 drugs)- are growing in popularity but loosely regulated. As a result many people are sourcing them through compounding pharmacies or “research use only” channels, which raises concerns around safety and quality. Protocole wants to solve for both access and trust - positioning itself as a more structured alternative, offering clinician-guided protocols with products fulfilled through regulated pharmacy partners. The funding, led by Rare Capital, will support expansion of its clinical infrastructure. (Continue reading: Fitt Insider)

🌟 Industry moves and strategic shifts

📌 US: Muse Capital launches Optima, bringing its women’s health portfolio directly into elite sport. This programme pulls together many of Muse Capital’s own portfolio of startups across menopause care, fertility, hormone tracking and breast imaging - including Midi Health, Cofertility and Eli Health - and gives athletes access to them in one place. For example, Eli Health’s hormone tracking tools can provide real-time cortisol insights, helping athletes better understand stress, recovery and performance. Piloting with the Red Bull Italy SailGP Team, the model is about taking existing women’s health products and putting them directly into high-performance environments. It’s effectively a curated marketplace built from Muse Capital’s own portfolio, applied to the fast-growing world of women’s sports - where revenues are now growing 4.5 times faster than men’s, yet female athletes continue to be underserved by sports science. (Continue reading: FutureFemHealth)

📌 US: Sibel Health secures FDA clearance for wireless maternal monitoring platform. The ANNE Maternal uses wearable sensors to continuously track maternal and fetal health without the wires of traditional systems - meaning more mobility and comfort during labour. It moves away from the static, bed-bound monitoring that’s long been the norm. Backed by $17.5m from the Gates Foundation and already being tested in countries including India and Nigeria, the platform is being built for both US care settings - where outcomes remain uneven - and lower-resource environments globally. It’s a good example of how maternal health innovation is starting to focus not just on new tech, but on how that tech actually gets used in the real world. (Continue reading: FutureFemHealth)

📌 US: Waters Corporation secures FDA clearance for at-home cervical cancer screening kit. Self-collection for HPV is moving more into the mainstream, particularly after policy shifts and endorsements in recent years. The Onclarity self-collection HPV test, allows patients to take samples at home and mail them to a lab for analysis, aiming to expand access to screening for those who are currently under-screened. (Continue reading: PR Newswire)

📌 US: Maven Clinic expands fertility programme to focus on earlier diagnosis. There’s a huge opportunity in fertility to help patients identify issues sooner, move to the right care faster and avoid costly IVF where possible. Maven is adding upfront lab testing, condition-specific care pathways - starting with PCOS - and integration with wearable data from the Oura Ring. It’s recognition that earlier, more data-driven support can manage costs and outcomes for employers, as well as do the best for patients too. (Continue reading: PR Newswire)

📌 US: Inito launches multi-hormone fertility reader for home use. Most at-home ovulation tests only track LH and provide a simple yes/no result, but Inito’s device is designed to show how hormone patterns change across the cycle, with the goal of giving a more complete picture of fertility. Its new InSight Wireless Reader tracks four key hormones - including estrogen, LH and progesterone - aiming to move beyond traditional single-signal testing. With built-in Wi-Fi, users can start a test and receive results in the app when complete. Backed by a dataset of over 40 million tests and peer-reviewed research, and positioned as “lab-grade” at home, it’s an example of the broader move towards more continuous, data-rich fertility tracking. Inito previously raised a $29m Series B in late 2025. (Continue reading: Business Wire)

📌 US/ GLOBAL: Is Sun Pharma prepping a $12b offer for Organon? Rumours are circulating that women’s health focused pharma company Organon is set for acquisition, with shares jumping as much as 18% on initial news. India’s largest pharma company Sun Pharma is said to be eyeing up the deal, to help it with US and European expansion and into specialty drugs with stronger pricing power and thinner competition. All rumours only for now but we’ll keep tracking this story. (Continue reading: First Word Pharma)

📌 PORTUGAL: First ever map of the ecosystem in Portugal. The team at FemTech Portugal have mapped 21 innovators in nine categories across the country’s ecosystem. Tellingly, six entire areas including chronic conditions, aging and bone health and cardiovascular health have no one building in them. The overwhelming majority of Portuguese FemTech sits at idea or early stage - however there is one unicorn too (Sword Health including Bloom) and almost nothing in between. (Continue reading: FemTech Portugal on LinkedIn)

🩸 Research and women’s health news

📌 GLOBAL: Researchers discover new type of cell that’s seen only during pregnancy. Researchers have discovered a previously unknown type of cell that appears only during pregnancy - and, for now, they’re not entirely sure what it does. The cells were found in placental tissue and may play a role in how the body supports and regulates pregnancy, but their exact function remains unclear. It’s an early-stage finding, but one that reminds us just how little we know about female physiology and how even fundamental aspects of pregnancy biology are not yet fully understood. (Continue reading: Live Science)

📌 DENMARK: 300,000 women invited to the country’s largest survey of women’s health. Researchers at Aarhus University are inviting 300,000 women aged 35–60 to take part in one of the country’s largest surveys on women’s health and wellbeing. Covering areas from sleep and pain to work and healthcare experiences, the study aims to better understand how women’s health develops over time - and why women tend to live more years in ill health than men. With follow-up planned in five years, the project is a great example of a growing push to build more representative, long-term data. (Continue reading: Aarhus University)

📄 Policy watch: risks and opportunities

📌 US: Maternity care is being “unbundled” - and it could reshape how pregnancy is paid for. For decades, prenatal care, delivery and postpartum support have been covered under a single bundled payment. But from 2027, that model will be broken apart, with each visit, scan and intervention billed separately. Advocates say this better reflects modern, more complex pregnancies and team-based care. But others warn it could lead to more fragmentation, higher costs and new incentives that favour intervention over prevention — particularly for low-risk pregnancies. At its core, the shift highlights a bigger tension: how to pay for maternity care as it becomes more specialised, data-driven and distributed. Maven’s Neel Shah MD breaks down what happens when health care outgrows the system to pay for it. (Continue reading: Maven Preprint)

📌 US: Estrogen patch shortages leave patients scrambling. More than 1 million US women begin menopause each year, but for decades fewer than 5% have used hormone replacement therapy. Now, demand is rising fast - particularly after the FDA removed the black box safety warning in November - with a surge in use of estrogen patches to treat symptoms like hot flashes, mood swings and sleep disturbances. But supplies can’t keep up and patients are struggling to access the hormone replacement therapy, with some forced to switch treatments or go without. The FDA has flagged the issue, but industry sources say the shortages could last for up to three years. Patch use surged by 26% in February, showing how quickly access can break down, even for common treatments. (Continue reading: Reuters)

📌 UK: New Women’s Employment Ambassador role announced as workplace health drive begins. A near-record high of 1.48 million women in the country are currently economically inactive due to long-term sickness. Women’s health campaigner and broadcaster Mariella Frostrup has now been appointed in a newly-created role of the Government’s Women’s Employment Ambassador. The appointment comes ahead of the upcoming Women’s Health Strategy refresh and as businesses are being encouraged to publish voluntary action plans to better support employees experiencing menopause symptoms. The Government says £1.7 billion is currently lost each year due to sick days, lost productivity and women leaving the workforce because of the menopause. (Continue reading: Gov.UK)

📆 Save the date

📌 AUSTRALIA: Breaking the silos: the women’s health medtech summit. Sydney, May 27-28.
This inaugural event is dedicated to addressing long-standing gaps in research, innovation, and policy affecting women’s health in Australia. The program brings together leading voices shaping the national conversation on women’s health in MedTech - spanning media, policy, research, and industry - to drive real system change.
🎟️ Tickets here.

📌 UK: CensHERship - women’s health marketing, storytelling and fundraising. London, April 21, 3.45pm BST.
A panel and workshops exploring the specific marketing challenges that founders in women’s health face when it comes to building a brand. Featuring my CensHERship co-founder Clio Wood!
🎟️ Register here.

📌 VIRTUAL: Menopause 2.0 ‘Understanding perimenopause before menopause’. May 6.
Women of Wearable’s third annual virtual conference on menopause, this year featuring speakers from Natural Cycles, Amissa Health, Mayo Clinic and more.
🎟️ Tickets here.

That’s all for this week! If you’ve missed any previous newsletter issues catch them all at futurefemhealth.com and do make sure to follow us on LinkedIn and you can connect with me directly.

Anna

Digital health company Sibel Health has received US FDA 510(k) regulatory clearance for its wireless maternal and fetal monitoring system, as it progresses development of less restrictive, more continuous monitoring during pregnancy and labour.

The ANNE Maternal platform is a fully wireless system designed as an alternative to traditional wired monitoring currently used. The system uses soft, flexible wearable sensors applied to the skin to continuously capture maternal vital signs - including heart rate, respiratory rate, oxygen saturation and temperature - alongside fetal heart rate and uterine activity. Data is streamed wirelessly to clinicians, with real-time monitoring and alerts.

This follows on from Sibel Health’s funding extension in October 2025 which brought its Series C round to $39 million. The company has also previously received grant funding of $17.5m from the Gates Foundation to support development of the platform for use in low- and middle-income countries.

"What makes this platform truly unique is its dual mandate: it meets the rigorous clinical standards demanded by the FDA while also being designed for deployment in the world's most resource-limited settings,” said Steve Xu, MD, CEO and Co-Founder of Sibel Health.

“That convergence - high-income market validation and global health impact in a single platform - is what we've been building toward since day one. We are deeply grateful to the Gates Foundation, whose continued investment has made this product possible, and to our global partners whose clinical expertise and dedication to global health have been indispensable. Together, we are closer than ever to making continuous maternal monitoring a universal standard of care.”

Moving beyond wired monitoring

Maternal–fetal monitoring has long relied on cardiotocography (CTG) systems, which typically require patients to remain connected to bedside machines via belts and wires. While widely used, these systems can limit mobility and are often associated with discomfort during labour.

Sibel Health’s ANNE Maternal platform aims to address those constraints by using wearable, wireless sensors to continuously capture physiological data from both mother and fetus.

By removing wires from the setup, the system is designed to allow greater freedom of movement for patients while maintaining clinical-grade monitoring - and this could have implications for both patient experience and clinical workflows.

The clearance arrives as the U.S. maternal mortality rate stands at 22 deaths per 100,000 live births - the highest of any high-income nation and more than double the rate of most comparable countries. For the fourth consecutive year, the March of Dimes awarded the U.S. a D+ in maternal and infant health, describing the system as "dangerously stalled."

Sibel’s system is also already being deployed in research settings across India, Pakistan, Nigeria and Rwanda, in collaboration with the University of Edinburgh and partners including Aga Khan University and the University of Rwanda.

Globally, around 700 women die each day from complications related to pregnancy and childbirth, the majority in settings without access to basic monitoring.

A growing focus on maternal health innovation

Wireless and wearable monitoring technologies have gained traction in recent years, particularly as healthcare systems look to expand remote and continuous monitoring capabilities. In maternal care, this has translated into efforts to improve how data is captured during pregnancy and labour, as well as how risks are identified earlier.

Sibel Health has previously focused on wireless biosensor platforms across neonatal and adult care. The ANNE Maternal system extends that approach into obstetrics, combining multiple monitoring functions into a single platform.

While FDA clearance is a key regulatory milestone, it does not guarantee widespread adoption - this will require hospitals to integrate wireless systems into its existing workflows, train staff and replace traditional CTG monitoring which may be deeply embedded.

However, wireless maternal monitoring has potential beyond the hospital setting, which could help to expand access in lower-resource settings.

A broader push toward access

Sibel Health’s wireless approach also sits within a wider set of efforts aimed at expanding access to maternal care - particularly in settings where traditional infrastructure and specialist capacity are limited.

Recent developments point to a growing focus not just on new technologies, but on how care is delivered. In the US, startup DeepEcho recently received FDA Breakthrough Device Designation for a simplified prenatal ultrasound system designed to reduce reliance on highly trained operators. The platform uses a “blind sweep” approach, allowing providers to capture data without needing to identify precise imaging angles, with software extracting key measurements.

Elsewhere, global health initiatives are focusing on scaling tools that already exist. A $52m programme led by Unitaid, in partnership with the Clinton Health Access Initiative and Amref Health Africa, aims to expand access to treatments for conditions such as preeclampsia and anaemia - both major drivers of maternal mortality despite well-established, low-cost interventions.

Together these efforts highlight how improving maternal health outcomes is not only about developing new technology, but making sure that technology can reach - and be effective - within the settings it is most needed.

A group of women’s health startups spanning fertility, hormone tracking and breast imaging are being brought directly into elite sport through a new programme launched by venture firm Muse Capital.

The initiative, called the Optima Program, will see a cohort of companies deployed to support female athletes and sports executives, marking a shift in how women’s health innovation is applied within professional sport.

A bundled approach to athlete health

The programme is being positioned as a response to what its founders describe as a historic mismatch between sports science and female physiology.

“For too long, the sports industry has applied a ‘one-size-fits-all’ approach to performance that ignores the biological uniqueness of women,” said Assia Grazioli-Venier, co-founder of Muse Capital.

Rather than focusing on a single product or intervention, Optima aggregates a range of services into what the firm describes as a “360-degree” model of care.

The initial cohort includes Midi Health (menopause and longevity), Cofertility (fertility care), Eli Health (hormone tracking), BeSound (breast screening), and Mavida Health (maternal and mental health), alongside wellness and consumer health brands including Beekeeper’s Naturals, Sequel, Hugh & Grace, SISTERLY and Mahmee.

Together, they cover a wide spectrum of needs that are often treated separately - from menstrual and hormonal health to fertility planning, postpartum care and cancer screening.

By integrating multiple companies into a single platform, Optima is effectively acting as a distribution channel - connecting early-stage and growth startups with elite athletes as end users. Many of the participating companies are in Muse Capital’s own portfolio.

Several of the participating founders framed this as an opportunity to move beyond consumer or clinical settings.

Marina Pavlovic Rivas, chief executive of Eli Health, said the programme would allow the company to deliver real-time cortisol insights directly to athletes, pointing to the impact of stress and recovery on performance and injury risk.

"For decades, the unique needs of female athletes have been an afterthought or ignored completely, she said.

“Cortisol imbalances - driven by intense training loads, inadequate recovery, and chronic stress - have measurable consequences for athletic performance, injury risk, and hormone health. Joining the Optima Program is an incredible opportunity for Eli to deliver real-time cortisol insights directly to the elite female athletes who need them, furthering their acceleration in sport.”

At Cofertility, co-founder Lauren Makler highlighted the tension many athletes face between performance and long-term reproductive decisions, describing Optima as a way to support “the whole woman”.

"At Cofertility, we know the importance of supporting women through deeply personal health decisions,” Lauren said.

“Through our model, where we expand access to fertility care by making egg freezing free when women donate half the eggs retrieved, we've worked with women and athletes across the country. Many have shared that pursuing excellence in their craft often meant feeling pressure to prioritize their goals at the expense of personal well-being or future plans.”

A disconnect in women’s sports

The launch of Optima comes at a key moment in women's sports. While women's professional sports revenue is growing 4.5 times faster than men's, female athletes have continued to be underserved by sports science.

Following recent multi-million dollar global investments in women's health research, Muse Capital and Optima say that they are the first to bridge the gap between innovation and application, by placing cutting-edge technology in the hands of women right now.

The programme is being piloted with the Red Bull Italy SailGP Team as part of SailGP’s Impact League, with access extended to athletes and executives across the competition.

Muse Capital said discussions are underway to expand the model to additional leagues and teams, although no further partnerships have been confirmed. Technology infrastructure for the programme is being provided by Flywheel Ventures Group.

A venture-backed model for deployment

The launch also highlights the role venture firms can play beyond funding, acting as intermediaries that shape how and where their portfolio companies are deployed. In this instance, Optima’s model is essentially functioning as a curated marketplace for women’s sports- closely aligned with Muse Capital’s own portfolio and its sports advisory and investment arm Muse Sport.

🌟 In this week’s briefing:

• 💡 The PCOS opportunity - a deep dive

• 💰 Sub-Q Bionic raises $1.5m for lymphedema implant

• 🤰🏼 Maternal health company Simplifed raises $10m Series A

• ✅ Egg freezing demand leads to new infrastructure support

Share your news: anna@futurefemhealth.com

💡 The PCOS opportunity: a deep dive into this unsolved area of women’s health

After more than a decade of campaigning work spearheaded by the UK charity Verity and Australia’s Monash University, Polycystic Ovary Syndrome is about to be renamed.

It’s a big deal - for patients, providers and anyone who has worked in the space. Because for years, the name has shaped how PCOS is understood, diagnosed and treated - and arguably has contributed to the speed (or lack of) progress.

Described by one patient as ‘misleading, medically outdated and emotionally invalidating’, ‘Polycystic Ovary Syndrome’ has never accurately represented PCOS as a condition. It centres the ovary, it suggests cysts and it reinforces the idea that this is predominantly a reproductive issue.

And while PCOS is a leading cause of infertility - affecting up to 80% of women with the condition - that’s never been the full picture.

PCOS is now more accurately understood as a lifelong metabolic and neuroendocrine condition - not just something that shows up when someone is trying to get pregnant. It’s associated with a 2–3x higher risk of developing type 2 diabetes, significantly increased rates of depression, and a substantially higher risk of cardiovascular disease.

The name change is therefore much more than a ‘rebrand’. It’s going to have positive impacts for innovators, investors and operators. It expands the market beyond fertility into chronic disease, brings new types of players into the space, and helps explain why some of the progress around PCOS has been slow to date - and why that is starting to change.

I’ve written a new FutureFemHealth deep dive to explore the big questions in PCOS:

🔍 why has PCOS been so difficult to solve?

🔍 what does the emerging innovation landscape look like? I’ve mapped it from GLP-1s and hormone-targeting therapies to care platforms, diagnostics and supplements

🔍 what are the signals that will determine whether this becomes a real, scalable category?

Read the deep dive in full here or click the button below:

Read the full PCOS deep dive

💰 Capital flows

📌 US: Sub-Q Bionics raises $1.5m pre-seed to modernise lymphedema care. Lymphedema - a chronic and painful condition often affecting women after breast cancer treatment - remains underserved, with care largely limited to compression and manual management rather than targeted therapies. Sub-Q Bionics is developing a implantable system designed to deliver therapeutics subcutaneously, offering a more precise and continuous treatment approach. While early, the platform signals a shift toward more active, tech-enabled management of conditions that have historically lacked innovation. (Continue reading: Business Wire)

📌 US: SimpliFed raises over $10m in Series A funding to expand in maternal health. Virtual maternal health company SimpliFed began with origins in breastfeeding and baby feeding support - offering judgment-free guidance to parents through their feeding journeys while also addressing broader maternal health needs. Fresh with funds, the company will now grow its proprietary maternal health operating system which integrates with health plans, providers, partners and health systems for secure data exchange and smoother workflows. (Continue reading: FinSMEs)

📌 CANADA: Flora Fertility raises $5m for customer-owned reproductive insurance. While 1 in 6 people are impacted by infertility globally, Flora says that fewer than 2% of those who need treatment can actually afford it. The start-up offers a D2C subscription model with policies starting at $20 per month to cover the full spectrum of treatment, diagnostics and medication. And because the insurance isn’t tied to a job, the coverage can go with the subscriber wherever they work. This round was led by ManchesterStory. (Continued reading: Athletech News)

📌 CANADA: Coral raises C$4million to expand virtual midlife women’s health platform across country. In just a year since launch Coral has now raised over $8m - with this latest capital supporting national scaling to the approximately 20 million Canadian women navigating menopause and midlife health. Coral reports more than 70% of its members report reduced symptoms within 90 days. This funding round was led by Brightspark, Diagram. AQC Capital and Anges Quebec and The51, with angel investors supporting. (Continue reading: Pulse 2.0)

🌟 Industry moves and strategic shifts

📌 US: Reprotech and TMRW Life Sciences consolidate to create fertility cryostorage company. As egg freezing grows, IVF is also seeing more frozen cycles rather than fresh. Clinics are feeling the strain of storing and managing rising volumes of reproductive material. Reprotech and TMRW are merging to meet that demand, combining physical storage scale with digital tracking and automation. Together they already partner with approximately 75% of fertility centers nationwide and support over half of patient cycles. The duo said it also positions them well for internal expansion in time. (Continue reading: Reprotech)

📌 US: Family building platform Sunfish launches AI-powered egg freezing program with cost guarantee. And if you needed another proof point for the rising demand for egg freezing, this is it. Sunfish is tackling one of the biggest barriers to egg freezing - cost uncertainty - but offering a data-driven plan with a target number of eggs, and covering a second cycle if patients don’t reach it. The model combines proprietary AI-powered predictions with financial guarantees, shifting more of the risk away from patients and onto the provider - making things more structured and consumer-friendly. (Continue reading: Fierce Healthcare)

📌 US: Maven Clinic partners with Wellthy to expand into end-to-end family care. Virtual care clinic Maven has recognised that its patients aren’t just facing fertility issues, pregnancy or menopause but they are also part of the ‘sandwich generation’ - balancing care for children alongside ageing parents. This new partnership brings together clinical care with hands-on caregiving support (childcare, eldercare, complex care navigation). It’s a win for employers too, who are looking for these sorts of integrated platforms to support their employees through the whole of life’s ups and downs. (Continue reading: Maven)

📌 US: Women's Health Week USA is making the case that the sector's biggest challenge in 2026 isn't innovation, it's scale. Taking place May 13-14 at the New York Academy of Medicine in New York City, the event brings together 600+ investors, founders, corporates, policymakers and clinicians around one question: how do you take women's health from growth to infrastructure? With speakers from Maven Clinic, the FDA, Google, Planned Parenthood, Organon and Hologic confirmed, the programme spans capital deployment, M&A strategy, regulatory pathways and the commercial case for equity. A mainstage Pitch Session across two categories, Medical Devices & Therapeutics and Consumer & Tech, opens the floor to the next wave of innovators. Early bird pricing closes April 17. (Continue reading: FutureFemHealth (partner content) or head straight to early bird tickets here)

📄 Policy watch: risks and opportunities

📌 US: Proposed federal budget signals cuts to medical research - with no clear focus on women’s health. Early analysis of the FY2027 budget request points to a >12% reduction in Department of Health and Human Services funding, including a $5bn cut to NIH. Notably, there is little to no explicit mention of women’s health research - raising concerns about how (or whether) it is being prioritised at a federal level. While presidential budgets aren’t binding, they are a strong signal of policy direction - and this one suggests more potential headwinds for research funding and long-term innovation in women’s health. (Continue reading: SWHR)

📌 UK: Maternity deaths at 20-year high as NHS ‘ignores warnings’. More than 12 women per 100,000 are now dying in pregnancy, childbirth or within six weeks of giving birth, a new investigation has revealed, the highest level since 2005. Hundreds of recommendations over a decade-long period have not been implemented to help improve treatment - including dozens regarding the most serious and potentially fatal ‘red flag’ symptoms. The biggest killer remains blood clots - which are often treatable if caught early. More than 30 recommendations have also focused on improving access to mental health services. Another review of maternity services in England is due this year. (Continue reading: The Times - paywall)

That’s all for this week! If you’ve missed any previous newsletter issues catch them all at futurefemhealth.com and do make sure to follow us on LinkedIn and you can connect with me directly.

Anna

Before you go:

After more than a decade of campaigning work spearheaded by the UK charity Verity and Australia’s Monash University, Polycystic Ovary Syndrome is about to be renamed.

It’s a big deal - for patients, providers and anyone who has worked in the space. Because for years, the name itself has shaped how PCOS is understood, diagnosed and treated - and arguably has contributed to the speed (or lack of) progress.

Described by one patient as ‘misleading, medically outdated and emotionally invalidating’, ‘Polycystic Ovary Syndrome’ has never accurately represented PCOS as a condition. It centres the ovary, it suggests cysts and it reinforces the idea that this is predominantly a reproductive issue.

And while PCOS is a leading cause of infertility - affecting up to 80% of women with the condition - it’s never been the full picture.

PCOS is now more accurately understood as a lifelong metabolic and neuroendocrine condition - not just something that shows up when someone is trying to get pregnant. It’s associated with a 2–3x higher risk of developing type 2 diabetes, significantly increased rates of depression, and a substantially higher risk of cardiovascular disease.

The name change is therefore much more than a ‘rebrand’. It’s going to have positive impacts for innovators, investors and operators. It expands the market beyond fertility into chronic disease, brings new types of players into the space, and helps explain why some of the progress around PCOS has been slow to date - and why that is starting to change

In this FutureFemHealth deep dive we explore some of the big questions in PCOS:

• what makes PCOS so complex

• is it possible to build a single ‘PCOS solution’ - or whether point solutions will win

• why innovation has lagged in this area

• who are the companies building in this space

• what other drivers might finally shift this market

What we get wrong about PCOS - and why it’s difficult to solve

Speak to any PCOS patient and you’ll likely hear variations on the same story:

• “They only really cared when it came to having children — at that point it was IVF.”

• “In my 20s I was just put on the pill — the go-to ‘solution’ for PCOS.”

• “I’ve been left experimenting with nutrition, exercise and supplements to try to manage skin and weight.”

• “I was told my symptoms were ‘normal’, or just about my weight - and I felt dismissed when I tried to push for answers.”

Part of the problem is that PCOS does not present in one clear, consistent way.

It can show up as fertility issues, irregular cycles, acne, weight changes, hirsutism, hair loss, insulin resistance and mental health challenges. Diagnosis - most commonly based on the Rotterdam criteria relies on identifying a combination of symptoms rather than a single underlying cause.

Despite affecting around 10-13% of women globally, it remains underdiagnosed, with many women navigating symptoms for years before receiving answers.

At the same time, PCOS cuts across multiple healthcare categories: fertility, metabolic disease, cardiometabolic risk and mental health. Then in practice it is still most often framed and treated as a reproductive condition, or worse, a ‘cosmetic’ one (weight gain and acne).

This is the mismatch.

Because emerging research now points to PCOS as an early-life risk profile with lifelong implications, where earlier intervention could materially change long-term outcomes.

In other words, PCOS often begins earlier - and runs deeper - than the way we currently treat it.

This is what makes PCOS so difficult to solve.

PCOS is not a single, clearly defined disease. Increasingly researchers and clinicians argue that what we call PCOS may be a set of related - and potentially distinct - conditions involving overlapping systems such as insulin resistance, neuroendocrine disruption (including LH/FSH signalling), androgen excess and chronic inflammation.

For some patients this results primarily in infertility, for others dermatological symptoms such as acne or hirsutism, and many, they may show signs of metabolic dysfunction with long-term health implications.

So, if different PCOS subtypes are driven by fundamentally different mechanisms - then a single therapy is unlikely to work for everyone.

But complex science is only part of the story.

The incentives bottleneck

The other complexity for PCOS care - and arguably the most important one - is incentives.

Clinical understanding is starting to catch up. International PCOS guidelines increasingly reflect the condition’s metabolic, reproductive and pyschological dimensions. They are well-established and adoption is expanding (the UK’s National Institute for Health and Care Excellence will adopt them soon).

But all this still doesn’t translate into aligned incentives.

For decades, most PCOS patients have been managed using inexpensive, widely available drugs.

Typically that means:

• oral contraceptives to regulate cycles

• medications such as metformin to address insulin resistance

• anti-androgens to manage symptoms like acne and excess hair growth.

Fertility treatments are then introduced when pregnancy becomes a priority.

These options can help with symptoms, but they do not change the underlying course of the condition.

This creates a difficult starting point for innovation.

When existing treatments are cheap, widely available and ‘good enough’ for symptom management (according to the system, not patients), any new therapy has to clear a much higher bar - not just clinically, but economically.

At the same time, many of the most visible symptoms of PCOS - such as infertility or excess hair growth — are often framed within healthcare systems as lifestyle or elective concerns rather than part of a chronic metabolic condition.

So all of this shapes how treatments are reimbursed, how research is prioritised and ultimately where investment flows.

In practice, this is reinforced by how PCOS is coded and paid for - particularly in systems like the US. Rather than being recognised and reimbursed as a distinct, lifelong condition, PCOS is often broken apart into its downstream effects: fertility treatment, diabetes risk, cardiovascular health, or mental health support.

That fragmentation makes the condition harder to “see” as a single disease entity within the system. And when a condition is not clearly defined in coding and reimbursement terms, it becomes much harder to build pathways for earlier intervention - or to justify investment in treatments that aim to change its long-term trajectory rather than manage its symptoms.

So, for many companies innovating in the space, the challenge is not just scientific but economic. How do you build a clear, defensible value story when the condition itself is heterogeneous, outcomes play out over the long-term, and existing treatments - however imperfect - are inexpensive?

Without strong health economic evidence showing how earlier or more targeted interventions reduce later costs, PCOS can appear difficult to underwrite compared to more clearly defined disease areas.

This is not just a theoretical challenge. A 2026 white paper from the Artemis Women’s Health Foundation describes a structural stalemate across the system — where incentives across payers, regulators and industry are not aligned to support new therapies. As a result, the drugs pipeline for PCOS is incredibly thin.

Meanwhile, the fertility sector has built a large and profitable industry around assisted reproduction. For many patients, IVF becomes the default escalation pathway - this reinforces a model focused on late-stage intervention rather than early disease modification.

There are early signs of the scale of this mismatch. In the US alone, direct healthcare costs linked to PCOS are estimated to exceed $15 billion annually. And yet no therapies are approved specifically to treat its underlying causes.

In effect, the system is currently paying significant amounts to treat the consequences of PCOS - but not to change its trajectory.

This is the paradox at the centre of the PCOS market.

In summary, no single stakeholder is fully incentivised to solve PCOS - despite the fact it carries long term risks including diabetes, cardiovascular disease and endometrial cancer. And alongside this, the condition also generates billions in healthcare costs through infertility care, metabolic disease and associated complications.

These costs are distributed across fertility clinics, primary care, endocrinology, and long-term chronic disease management - often coded, funded and managed as separate issues across different budgets, systems and time horizons.

And when a condition isn’t fully owned by any one part of the system, the incentives to invest in long-term, disease-modifying solutions remain weak.

Now, it’s exactly this gap — between biological complexity, economic incentives and patient need — where a new generation of innovators is beginning to focus.

The forces driving new innovation

There’s a number of forces which are driving new innovation in the PCOS space:

• patient-driven entrepreneurship - a number of founders in the space have experienced PCOS themselves and have a deep understanding of what gaps to fill and how to speak to patients in a way that actually resonates.

• a white space left by the lack of a pharmaceutical drugs pipeline. As discussed earlier, PCOS has historically relied on repurposed medications such as oral contraceptives, metformin and fertility drugs. While these treatments can alleviate symptoms, they do not address the underlying condition - leaving significant white space for new approaches.

• evolving science - PCOS is now being understood not as a single condition, but as a spectrum of metabolic, neuroendocrine and hormonal patterns. As large-scale patient datasets emerge, researchers are beginning to reveal distinct biological subtypes.

• New insights into the biology of PCOS - emerging research is reshaping how scientists understand androgen excess, a key driver of symptoms. For example, a group of hormones known as 11-oxygenated androgens, produced mainly by the adrenal glands, may play a larger role than previously thought.

Taken together these shifts are starting to change how PCOS is understood and where innovation is beginning to take hold. This all shows up in how the market is evolving.

Mapping the emerging PCOS innovation landscape

Globally, estimates of the PCOS market vary around $4.79 billion in 2024, with forecasts pointing to steady mid-single-digit growth through the early 2030s. Yet most of that revenue still comes from repurposed medications — oral contraceptives, insulin-sensitising drugs such as metformin and fertility treatments.

The companies and technologies emerging around PCOS suggest that innovation is forming across several distinct layers of the ecosystem.

Rather than being driven by a single breakthrough drug, the space is evolving across therapeutics, care models, digital infrastructure, supplements and diagnostics.

This pattern reflects the unusual structure of the market itself.

In other words, the current market remains dominated by symptom management, while much of the real innovation is happening around the edges. Rather than a single category, PCOS is emerging as a multi-layered ecosystem - spanning therapeutics, care delivery, consumer health, and data infrastructure.

Several areas of activity are beginning to emerge.

1. Treatments that address the root causes of PCOS

There is no cure for PCOS which means the largest opportunity in PCOS lies in treatments that address the underlying drivers of the condition, rather than simply managing individual symptoms.

As we’ve touched on above, most drugs currently used in PCOS were not designed for the condition itself. Instead, they target individual symptoms — regulating menstrual cycles, improving insulin sensitivity or inducing ovulation.

Researchers are now exploring therapies that act earlier in the disease and target the metabolic and hormonal pathways that drive PCOS itself.

Some of the main areas of activity include:

Metabolic therapies such as GLP-1s.

One of the most closely watched areas involves metabolic drugs, particularly GLP-1 receptor agonists originally developed for diabetes and obesity.

In the US, it’s estimated that 17.6% of women with a PCOS diagnosis now have a GLP-1 prescription, up from 2.4% in 2021.

These medications - including drugs such as semaglutide and liraglutide - improve insulin sensitivity and promote weight loss, both of which are believed to influence several PCOS symptoms.

Right now, they are not currently approved specifically for PCOS, but there is early research that suggests they may help improve metabolic health and hormonal balance in some patients.

In some ways, PCOS may benefit indirectly from the rapid innovation currently happening in metabolic medicine. And given the huge growth of GLP-1s globally, this is an important area to track, not least because these therapies may displace other innovation and reshaps the future PCOS treatment landscape.

Hormone-targeting and androgen-focused therapies

Another area of research is focusing on the hormonal signalling systems that regulate ovulation and androgen production.

In PCOS, these signals become disrupted, leading to excess androgen levels and irregular ovulation. The question now is whether intervening earlier in these pathways could help reset the system - rather than managing symptoms after they appear.

There are a few different directions emerging here:

Repurposing existing drugs

One of the more tangible developments comes from drug repurposing. A 2024 study found that artemisinin - a drug traditionally used to treat malaria - improved hormone levels and helped regulate menstrual cycles in people with PCOS.

It’s still early, but this is notable. Repurposed drugs can often move faster through development, raising the possibility of nearer-term options if larger trials are successful.

Targeting neuroendocrine signalling pathways

At the same time, research is increasingly focusing on how the brain regulates reproductive hormones.

This includes pathways such as:

• kisspeptin signalling, which plays a central role in triggering ovulation

• the neurokinin 3 receptor (NK3R), which helps regulate hormone release

Together, these point to PCOS not just a metabolic condition, but a neuroendocrine disorder involving disrupted communication between the brain, ovaries and adrenal glands.

These approaches remain largely pre-clinical - but they reflect a deeper rethinking of where intervention could happen.

Early-stage companies building on these pathways

A small number of companies are starting to translate this science into potential therapies.

For example, Sena Therapeutics is developing treatments that target hormone signalling pathways involved in reproductive function, with the aim of helping the body regulate hormones more effectively — rather than managing downstream symptoms.

Alongside this, there are also more traditional drug development approaches emerging. Celmatix launched a PCOS drug programme in 2023 (with its pipeline now acquired by Gedeon Richter), reflecting growing interest in building targeted therapies specifically for the condition.

Continued focus on fertility outcomes

At the same time, some innovation remains focused on specific endpoints — particularly fertility.

For example, Oxolife is developing an oral drug designed to improve embryo implantation and increase pregnancy rates. While being studied in PCOS populations, approaches like this are still centred on fertility outcomes — rather than addressing the broader metabolic and hormonal drivers of the condition.

Device-based approaches

Alongside drugs, some companies are exploring device-led interventions:

• May Health (France / United States) — a minimally-invasive ovarian procedure designed to restore ovulation in women with PCOS-related infertility. It has already received European CE Mark in 2025 and secured $11.7m in investment in early 2026 to continue pivotal trials and FDA submission. Note, of course, May Health targets PCOS-related infertility, not the whole syndrome.

• Neuraura (Canada) — aiming to deliver the first new PCOS treatment in 70 years, Neuraura’s ‘LoOop’ is an at-home neuromodulation device that uses low-frequency electrostimulation to improve insulin resistance and menstrual cycles and enhance ovarian blood flow.

While still early, these approaches point to a broader shift - from managing symptoms to trying to change the trajectory of the condition itself.

As understanding of PCOS improves, this is also likely to become a more segmented market, with different approaches emerging for different patient profiles.

That, in turn, suggests that effective treatment may not come from a single solution, but from combinations of therapies - spanning metabolic, hormonal, and potentially data-driven or behavioural approaches.

2. Integrated PCOS care platforms

Another emerging category is integrated care models that treat PCOS as a chronic metabolic-reproductive condition.

Today, PCOS care is often split across gynaecology, endocrinology, dermatology and fertility medicine. Patients frequently move between specialists with little coordination.

A new wave of companies is attempting to redesign this pathway.

These platforms typically combine telehealth, lifestyle support, metabolic monitoring and education into a single care model.

A common pattern emerging across patient communities is what happens after diagnosis. As one founder building in the space explained, “the most common question is: I’ve just been diagnosed with PCOS - now what do I do?”

This gap - between diagnosis and ongoing support - is exactly what these care platforms are built to address.

In practice, this is less about treating PCOS as a one-off condition, or something to be addressed only at the point of fertility, and more about managing it as an ongoing, day-to-day process.

Examples

• Allara Health (US) - virtual care platform combining endocrinology, dietetics and metabolic support. Founder Rachel Blank was herself diagnosed with PCOS after years of unexplained health issues. Allara raised a $26m Series B in early 2025.

• EsterCare (Sweden) - Telemedicine and workplace women’s health services. In 2025 EsterCare acquired PCOS-focused digital health app Ovulai.

• Solence (France) - AI-driven lifestyle programme focused on PCOS metabolic management. It offers tools for managing chronic conditions linked to PCOS. The first product is a patient app. Solence raised €1.6M in seed funding in July 2025.

• Aspect Health (US) - combines a glucose sensor, at home test kits, app and health coach to offer personalized plans and aims to address underlying causes of symptoms.

• Insara (formerly Lilli Health) (US) - digital care and support platform focused on hormonal health, including PCOS. Combines education, tracking, behaviour change and community.

• OvaJoy (UK) – very early-stage digital health platform focused on PCOS management, progressing toward biomarker-driven personalisation and regulated diagnostic tools. Founded by Anna Davies, following lived experience of gaps in PCOS care. OvaJoy has secured Innovate UK grant funding and is opening a pre-seed funding round to support regulatory readiness and further product development.

• Emmi Health (US) - very early-stage, personalized PCOS coaching platform delivering phenotype-specific lifestyle protocols across metabolic, adrenal, androgenic, and inflammatory hormonal drivers. Emmi pairs women with PCOS-specialized coaches and integrates symptom tracking, wearables, and lab data to surface what works for each individual. Founded by Jenny Westlund, who reversed her own PCOS markers through systematic biomarker tracking and n-of-1 experimentation, and built Emmi to close the evidence, support, and data gap between provider visits

In addition to the above a number of broader platforms also include PCOS as part of their offering, such as Visana, Pomelo Care and Tia. And, there is also growing interest from employers and benefits providers in women’s health more broadly, which could influence how PCOS care is funded and delivered.

3. An emerging layer of digital and data-driven PCOS care

Alongside clinical care platforms, there is a growing shift toward more data-driven and personalised approaches to PCOS.

In practice, many of these capabilities are being built into broader care platforms rather than emerging as standalone products.

PCOS generates large volumes of fragmented health data - menstrual cycles, hormone levels, metabolic labs, wearable signals and lifestyle factors. These platforms aim to bring that data together, helping patients and clinicians identify patterns over time.

AI is particularly well suited to this, given the complexity and variability of the condition.

Over time, this could enable a shift toward more personalised PCOS care, where treatment is tailored to individual profiles rather than standard protocols.

4. Supplements and metabolic support

Another major layer of the ecosystem sits in the supplement and nutritional therapy market.

In practice, supplements are often the first place patients turn after diagnosis. As I researched this article, one founder building in the space told me, “the first thing people ask is: what supplements should I take?” - highlighting both the demand for action and the lack of clear clinical guidance.

Many patients begin experimenting with supplements long before receiving formal diagnosis or specialist care - particularly those aimed at improving insulin sensitivity and metabolic health.

One of the most widely used categories is inositols (myo-inositol and D-chiro-inositol), which have been shown in some studies to support insulin sensitivity and menstrual regularity.

This has driven rapid growth in consumer-focused PCOS products - from targeted supplements to broader metabolic health programmes.

At the same time, a challenge is that unlike pharmaceuticals, supplements are often regulated under less stringent evidence requirements, making it difficult for patients to distinguish between evidence-based interventions and marketing claims.

Examples:

• Veera Health (India) - supplements plus a subscription model combining coaching and metabolic support

• Elan Healthcare (Canada) - doctor-led supplement company aiming to target specific conditions like PCOS, with formulations that work as well as metformin.

• Ovii (US) - created by a gynecologist, Ovii aims to support women with PCOS, perimenopause, menopuase and other hormonal and metabolic issues.

• A rapidly growing number of direct-to-consumer brands offering PCOS-specific formulations and hormone-support products such as India’s Gytree - a PCOS-specific protein supplement enriched with inositol.

5. Diagnostics and earlier detection

Finally, several innovations are emerging in diagnostics and biomarker testing.

Delayed diagnosis remains one of the most common frustrations for PCOS patients with many waiting for years for answers.

New approaches aim to simplify and standardise detection - especially through non-invasive and at-home testing.

Examples:

• Roche Elecsys® Anti-Müllerian Hormone (AMH) Plus immunoassay. This blood test already used by the NHS as a fertility indicator received CE mark approval to support the diagnosis of PCOS.

• Mira (United States) - an at-home hormone testing platform that measures multiple reproductive hormones to help monitor conditions like PCOS.

• Woost (UK) - menstrual blood research company developing diagnostic tools for conditions including PCOS.

• Hertility (UK) - hormone and fertility testing company with wrap-around support including a clinical results review call doctor-written report and clinical care plan.

Researchers are also exploring how metabolic biomarkers, hormone panels and digital health data could eventually enable earlier detection and more targeted care pathways.

Early stage work at Aberystwyth University is investigating whether conditions such as PCOS could be identified through non-invasive urine-based tests, pointing to a future where diagnosis may become significantly earlier and more accessible.

And of course, by identifying PCOS earlier it can be managed more proactively.

6.Evidence-based education and decision-support tools

Alongside commercial innovation there’s an important layer of the PCOS ecosystem: evidence-based education and decision-support tools.

These have often been developed by clinicians, researchers and public health institutions rather than startups - and in many cases have existed for longer than the current wave of venture-backed innovation.

Their role is different. Rather than delivering care directly, they aim to standardise information, support self-management and bridge the gap between diagnosis and ongoing support.

This matters in a condition like PCOS, where patients are often left navigating fragmented care and inconsistent advice - and where demand for information has outpaced what healthcare systems currently provide.

Examples include AskPCOS, a clinician-developed app from Monash University that provides guideline-based information, symptom tracking and decision support tools.

Where the PCOS innovation landscape could go next

Innovation in PCOS is still at an early stage. Several structural shifts could determine how the ecosystem evolves over the coming decade.

1. AI and data-driven care

The complexity and variability of PCOS make it well suited to data-driven approaches. Over time, AI systems may help identify patterns across hormonal, metabolic and lifestyle data - enabling more personalised treatment pathways and earlier detection of risk.

2. Awareness and the narrative shift

The imminent name change of PCOS will help to reframe PCOS as a lifelong chronic condition. In turn this could reshape how it is researched, funded and treated.

Right now a large proportion of PCOS cases remain undiagnosed. As awareness grows, more women are likely to seek diagnosis, treatment, and support - not just for symptoms, but for long-term health risks.

At the same time, declining use of the contraceptive pill may speed up demand for alternative approaches.

3. The economic opportunity

PCOS already carries a significant economic burden - through healthcare costs, reduced productivity, and long-term chronic disease.

Much of this cost is indirect or delayed, which makes it harder to measure - but no less real.

As understanding improves, there is a growing case for earlier intervention - not just clinically, but economically.

4. Who pays

As new diagnostics, digital tools and therapies emerge, reimbursement will become a central question.

If PCOS is recognised more clearly as a chronic metabolic condition, payers may begin to see earlier intervention as a way to prevent downstream costs in diabetes, cardiovascular disease and fertility treatment.

Until then, much of the innovation sits outside of traditional reimbursement pathways.

5. Information quality and misinformation

The rise of online PCOS communities has highlighted the demand for accessible health information - but also the risks of misinformation.

PCOS has become one of the most misinformation-prone areas of women’s health online, as patients turn to social media and digital platforms to fill gaps left by fragmented care.

Investigations have highlighted how some influencers promote expensive supplements, restrictive diets or unproven “cure protocols” for PCOS without strong clinical evidence.

Despite growing demand, the quality of products in the market varies significantly. Founders in the space I spoke to point to issues such as incorrect formulations and misleading positioning - particularly as supplements are often marketed as “quick fixes” for a condition that is fundamentally complex and highly individual.

Demand for answers is outpacing what healthcare systems currently provide.

For innovators, this creates both an opportunity and a responsibility - with trust, clinical credibility and clear evidence standards becoming as critical as the underlying technology itself.

6. Supplement regulation

The supplement market around PCOS continues to grow rapidly, but regulatory oversight remains limited in many markets.

As the category expands, clearer standards around evidence and safety may become increasingly important.

7. Access and affordability

Many PCOS interventions - from fertility treatments to digital care programmes - remain expensive and unevenly distributed across healthcare systems.

Expanding access while maintaining clinical quality will be a key challenge as the ecosystem develops.

8. Awareness, behaviour change and whole person care

Finally, and importantly, overlapping issues such as weight management, stress, and mental health are driving a move towards whole-person care which addresses behavioural, psychological and metabolic factors. This will show up as increased focus on behavioural interventions such as lifestyle support as a core part of care and a rise in more integrated care models, particularly in digital health.

Conclusion

In many ways, PCOS illustrates the broader shift now happening across women’s health.

For decades the condition has sat awkwardly between specialties - part reproductive health, part metabolic disorder, part dermatology, part endocrinology. As a result, care has often been fragmented and innovation slow.

But that fragmentation also reveals the opportunity.

Because solving PCOS is not just about developing a new drug. It requires rethinking how women’s health conditions are diagnosed earlier, managed across the life course and supported through a combination of clinical care, digital tools and metabolic health interventions.

If that model succeeds here, PCOS may become more than just a neglected condition finally receiving attention.

It may become a blueprint for how the next generation of women’s health innovation is built.

• With thanks to Jenny Westland, Anna Davies and Colette Harris for their additional contributions to this deep dive.

You may also like some of our other deep dives (currently available for free):

Women’s health is at an inflection point. The validation phase is over. Capital is moving. Institutional players are entering. The question the sector is now asking isn’t whether women’s health deserves investment, it’s how to take it from growth to scale and build an industry designed to last.

That question is the organising principle behind Women’s Health Week USA 2026, taking place May 13-14 at the New York Academy of Medicine in New York City. With 700+ senior decision makers, 70+ speakers and 30+ sponsors confirmed, it is one of the most commercially concentrated gatherings in the women’s health calendar.

Early bird pricing ends April 17. Register here to save up to $600 on your place

What women’s health 2.0 actually means

The theme for 2026 is The Era of Scale, a deliberate signal about where the conversation needs to go.

When Women’s Health Week launched, the focus was on validation: proving demand, building product-market fit, attracting early capital in an overlooked category. But that work has been done. Women’s health now extends well beyond fertility and gynaecology into metabolic and autoimmune conditions, cardiovascular health, longevity, wearables, and AI-driven diagnostics.

Investments are making returns and investor confidence has grown, but a persistent growth-stage cliff is limiting how many companies reach true commercial scale. The next phase is not about proving demand. It is about institutionalising the category: moving from founder-led growth to system-led adoption, from specialist believers to generalist capital, from pilots to embedded infrastructure.

That is what two days in New York will be focused on.

The speakers

The lineup reflects the breadth of the ecosystem now engaged with women’s health as a commercial priority.

• Kate Ryder, CEO and Founder, Maven Clinic

• Mallika Mundkur, Deputy Chief Medical Officer, FDA

• Melanie Newman, Chief External Affairs Officer, Planned Parenthood

• Juan Camilo Arjona Ferreira, Head of R&D & Chief Medical Officer, Organon,

• Phylicia L. Woods, Senior Director of Government Affairs, Hologic

• Nichole Young-Lin, Clinical Lead for Women’s Health, Google

• Jill Angelo, VP Women’s Health, OURA

• David Stern, CEO of Kindbody

• Tammy Sun, CEO and Founder of Carrot Fertility

The full speaker list runs to 70+, with representation from the NYSE, ARPA-H, the World Health Organization, CVS Health Ventures, Natural Cycles, Novo Holdings, and more. View the full list here.

The programme

Day one opens with a focus on capital. The opening session, Who’s Backing the Boom: Inside the Capital Surge in Women’s Health, sets the commercial tone immediately, examining where institutional money is going and what unlocks the next wave of investment. Later sessions tackle the growth-stage cliff directly, alternative routes to scale beyond VC, and the regulatory landscape, including a fireside chat with the FDA and a panel on building the business case for reimbursement.

The afternoon moves into the digitisation of the sector: the wearable economy, data gaps and trust, and the role of AI in shaping the next generation of women’s health products.

Day two opens on equity, with Advocacy for Women’s Health in 2026: How Policy Drives (or Derails) Growth, followed by The Economics of Equity: How Inclusion Equals Growth Strategy, a session making the commercial case for addressing underserved populations. The afternoon shifts to commercialisation strategy, M&A dynamics, and the power of partnerships

View the full programme to find out more

Intelligence-powered matchmaking

What separates Women’s Health Week from a standard conference is the matchmaking infrastructure behind it. The W. Intelligence system collects 10+ structured data points from every attendee, including company stage, focus areas, strategic priorities and partnership goals, and uses that data to generate curated 1:1 introductions before the event begins. With 30+ meeting tables running all day across both days, the goal is straightforward: everyone leaves with at least one new partnership.

It’s this kind of impact that led Lindus Health to describe Women’s Health Week as “the best ROI on a conference we’ve ever had.”

The pitch sessions

Alongside the main programme, Women’s Health Week USA will host two Pitch Sessions on the mainstage, open to companies across two categories: Medical Devices & Therapeutics, and Consumer & Tech. Fifteen companies will be selected to pitch in front of the full audience of investors, corporates and strategic partners.

Any company treating a condition that affects women exclusively, differently, or disproportionately is eligible to apply. Applications are free and close April 10.

Apply to pitch

For those looking to attend rather than pitch, early bird registration closes April 17, after which ticket prices increase across all tiers.

Download the full programme

Register before April 17

This article is part of a partnership with Women’s Health Week.