Women's health smart ring EvieMed by Movano Health receives FDA Clearance
Pulse Oximeter component of the ring now FDA cleared
Movano Health has announced FDA clearance for the pulse oximeter in its EvieMED Ring - the medical-grade version of the first smart ring designed specifically for women.
This significant milestone now allows Movano Health to pursue large business opportunities in healthcare B2B markets (an estimated $40 billion TAM) where health monitoring solutions are needed for applications such as clinical trials, post-clinical trial management, and remote patient monitoring for both healthcare providers and payors.
John Mastrototaro, President and CEO of Movano Health said:
"We launched the Evie Ring in the consumer wearable market, but our broader goal has always been to provide a clinical-grade device for B2B channels,"
"This FDA 510(k) clearance marks a major milestone for the Company and expands our reach to pharmaceutical companies, medical device manufacturers and payors looking for a more accurate, consistent and comfortable health monitoring solution that would help improve compliance by fitting easily into patient lifestyles."
Partner pipeline fills
In anticipation of an expected 510(k) clearance, Movano Health has been collaborating with a number of potential partners across the healthcare industry.
The Company is currently in the agreement phase with a large payor for a pilot study with the EvieMED Ring planned for early 2025 related to the health management of high-risk populations and is also in discussions with a global pharmaceutical company and leading clinical research organization (CRO) to use the EvieMED Ring in upcoming clinical trials. The EvieMED Ring was also recently selected for a MIT study on long COVID and chronic Lyme disease.
"This milestone marks the beginning of our plans to accelerate distribution of EvieMED. With the significant foundational work in achieving our first clearance now behind us, we are eager to continue to collaborate with the FDA on securing additional clearances including respiration rate and other critical analytes and diagnoses," continued Mastrototaro.
"We also remain excited about the opportunities to leverage our proprietary radio frequency (RF) technology to address cuffless blood pressure and noninvasive glucose monitoring."
Why pulse oximeters matter
The FDA clearance is specific to the EvieMED’s pulse oximeter.
Pulse oximeters measure blood oxygen (SpO2) levels and heart rate, commonly used for monitoring chronic conditions such as asthma and lung cancer, or acute conditions such as pneumonia. They are also used for evaluating treatment effectiveness and for checking oxygen levels. Specifically to women’s health they can be used for pregnancy monitoring, postpartum care, sleep monitoring, menstrual health and chronic care management.
Conventional solutions for oxygen monitoring have significant shortcomings and can be uncomfortable, discouraging compliance that is needed to ensure reliable information for evaluating a patient's health.
The EvieMED Ring eliminates those limitations by combining the accuracy of a medical device with the comfort of a wearable that can be worn continuously, thanks in part to an award-winning design with a small gap in the ring surface and slight flex that accommodates finger swelling. A pivotal study also found that the EvieMED Ring produces accurate readings among users with darker skin tones as measured by the Fitzpatrick scale of skin color classification.
In addition, the EvieMED Ring collects wellness metrics including sleep, activity, temperature variability, calories burned and respiration rate that can give both patients and healthcare providers a broader picture of the user's overall wellness.
Female-focused
First announced in 2022 and then fully unveiled at CES back in 2023, 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.
A relaunch followed in September 2024 which promised deeper personalised health insights through improved AI-based pattern recognition. And the upgrade augments a trend analysis feature which it said ‘sets Evie apart from every other wearable on the market.’
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