www.fdanews.com/articles/210686-movano-health-plans-for-fda-clearance-of-hypoxia-and-heart-rate-smart-ring
Movano Health Plans for FDA Clearance of Hypoxia and Heart Rate Smart Ring
January 4, 2023
Pleasanton, Calif.-based Movano Health plans to file for FDA clearance of its Evie device — a smart ring for women that tracks oxygen saturation, heart and respiration rates, skin temperature, ovulation, menstrual symptoms, activity, calories burned, sleep and mood.
The company’s filing follows a clinical trial that demonstrated the wearable device’s accuracy in measuring oxygen deficiency and heart rate
The ring, which is made of polished aluminum, delivers results to a mobile app.
The device will offer women medical grade measurements “so they can better understand the ‘why’ behind what they're feeling,” the company said.