Movano Health has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its first commercial product, the much anticipated Evie Ring. The application has passed the initial review and is currently under full examination by the FDA.
The submission includes results from a pivotal hypoxia trial conducted with the University of California, San Francisco (UCSF). The Evie Ring displayed an approximate 2% margin of error for blood oxygen saturation (SpO2), below the FDA’s guidance of 3.5%. In another non-clinical test, the ring had a margin of error of 1 BPM for pulse, exceeding FDA standards.
The Evie Ring aims to offer more than basic metrics. It is designed to capture a range of health indicators such as heart rate, SpO2, respiration rate, skin temperature variability, and menstrual symptom tracking. Data is relayed through a mobile app designed to offer actionable insights to users.
John Mastrototaro, CEO of Movano Health, shared: “From the outset, our vision for Evie has been to develop a consumer wearable that is beautiful, accessible and personalized, as well as be cleared by the FDA as a medical device. This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings. The effort associated with becoming a medical device company is certainly significant, but we believe it’s a highly competitive differentiator and a strong asset when compared to existing wellness solutions. It also is expected to enable significant partnership opportunities with healthcare and other enterprises. We look forward to working with the FDA through the review process.”