Movano's 'Evie Med' women's smart ring now one step closer to medical device status
The device, which incorporates a pulse oximeter, is aiming for FDA approval as a commercial medical device
Movana Health has submitted clinical trial results and proof of enhanced medical device usability to the US Food and Drug Administration (FDA) as it continues to pursue commercial medical device status for its Evie Med Ring pulse oximeter.
Right now, Movano is only able to describe its women-focused smart ring, the Evie ring, as ‘medical-grade’ as it goes through the process with the FDA.
An FDA clearance would bring Movano Health a significant step closer in its goal to disrupt the wearables industry while unlocking significant partnership opportunities. The Company continues to expect a decision regarding its 510(k) clearance in July 2024.
"From the outset, our vision has been to develop a wearable that fits with any lifestyle and is cleared by the FDA as a medical device," said John Mastrototaro, CEO of Movano Health. "The exemplary results of our latest study are a critical component of our FDA filing and lay the groundwork to fulfilling all aspects of that goal."
Clinical trial progress
In January 2024, Movano Health completed a second hypoxia trial with the University of California, San Francisco (UCSF) confirming the accuracy of its Evie Med Ring pulse oximeter exceeds the FDA guidelines.
Notably, this accuracy applied to all skin tones on the Fitzpatrick Scale.
This latest UCSF study used the production model ring, which will be sold under the brand name ‘Evie Med’, and reflected several design improvements from the pre-commercial model used in an earlier study.
During the trial, each subject wore four Evie Med Rings. The four Evie Med Rings achieved a pooled root mean square error (RMSE) of 2.46% in over 800 paired samples, which was once again well below the FDA guidance of 3.5% for SpO2. Additionally, the Evie Med Ring's accuracy exceeded that of the two commercially available, hospital-grade reference pulse oximeters in the study.
Investing for the future
Movano Health also recently closed a $24 million private placement with a select group of institutional and accredited investors. As part of the transaction, the Company received a strategic seed investment from a tier-one multi-billion dollar medical device company and signed an agreement to explore future collaborations relating to development and commercialization.
This strategic investment combined with the recent clinical results solidify Movano Health's edge over traditional wellness trackers, paving the way for impactful partnerships with healthcare providers and other industry leaders.
The net proceeds of the private placement are expected to be used for general corporate purposes and working capital, including accelerating the development of Movano Health's proprietary technologies and wearable medical device solutions for healthcare enterprises, including pharmaceutical, medical device and health insurers.
The women’s health-focused smart ring
The Evie ring has been available since early 2024 - securing $1 m in advance sales on Black Friday 2023 alone - after being first announced in 2022. It’s currently sold out on its website.
The Evie Med Ring combines medical device and wellness metrics to give a full picture of one's health. In addition to pulse oximeter medical data (SpO2 and pulse), these wellness metrics will be provided:
Activity: log a workout, active minutes, steps, distance traveled, heart rate, and calories burned
Sleep: start time, stop time, duration, and cycles (awake, light, deep, and rapid eye movement (REM)), resting heart rate average, oxygenation maximum, heart rate variability, respiration rate, skin temperature variability average)
Women's health tracking: menstrual cycle and ovulation, mood, energy, and symptom tracking
Goal setting (sleep, active minutes, steps, mood and symptoms, workout sessions)
Daily Summary graphic (activity, calories, steps, and sleep, mood and energy logging)
This data is delivered through a companion mobile app which aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric data into actionable insights that will help consumers make manageable lifestyle changes and patients and their health care providers to take a more proactive approach to managing and treating chronic disease in healthcare and home environments.
.