The updated clinical results show the consumer sleep-tracking ring’s pulse oximeter exceeds FDA accuracy standards.
RT’s Three Key Takeaways:
- Movano Health has submitted updated clinical trial results and usability proof to the FDA for the Evie Med Ring, aiming for 510(k) clearance in July.
- Trials with UCSF confirmed the Evie Med Ring’s accuracy exceeds FDA guidelines and outperforms hospital-grade reference pulse oximeters across all skin tones.
- Movano Health secured $24 million in funding to accelerate the development and commercialization of its wearable medical devices.
Movano Health announced that it submitted updated clinical trial results, as well as proof of enhanced medical device usability, to the US Food and Drug Administration (FDA) as part of its 510(k) filing for the company’s first commercial medical device, the Evie Med Ring pulse oximeter.
The company continues to expect a decision regarding its 510(k) clearance in July.
“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,” says John Mastrototaro, CEO of Movano Health, in a release. “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 Trials
In January, 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 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 of 2.46% in over 800 paired samples, which was once again 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.
Securing Funding
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 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.
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 technologies and wearable medical device solutions for healthcare enterprises, including pharmaceutical, medical device, and health insurers.
The Evie Med Ring
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), 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, sleep, mood, and energy logging)
Photo caption: Evie Ring 2
Photo credit: File photo
