Movano submits smart ring for pulse oximetry to FDA

August 3, 2023 By Sean Whooley

The submission passed the first milestone of the review process — an initial review for completeness. It’s now under full FDA review for pulse oximetry measurements.

Pleasanton, California-based Movano unveiled the Evie smart ring designed specifically for women in December 2022. Evie offers intelligence and comfortability in a sleek appearance. It provides users with medical-grade health data for translation into personalized insights delivered through a mobile app.

Evie offers measurements for resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. It delivers data through a mobile application.

One aspect of the FDA submission comes in the form of clinical performance for the ring, Movano said in a news release. At the end of 2022, the company completed a successful pivotal hypoxia trial to evaluate the accuracy of Evie’s blood oxygen saturation (SpO2). Comparing the ring to arterial blood gas data, Evie achieved a 2% margin of error. That lands well below the FDA guidance of 3.5%.

A separate nonclinical test evaluated pulse over the range of 40 to 240 beats per minute (BPM). Evie’s margin of error came in at 1 BPM, also bettering guidelines from the agency.

“This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings,” said John Mastrototaro, CEO of Movano Health. “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.”

Filed Under: 510(k), Business/Financial News, Digital Health, Food & Drug Administration (FDA), Health Technology, Patient Monitoring, Regulatory/Compliance Tagged With: FDA, Movano Health