Pleasanton, California-based Movano designed Evie to offer 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.
The system requires no monthly subscription, according to a news release.
Movano plans to seek FDA clearance for Evie. It plans to file for pulse oximetry metrics after completing a hypoxia trial in October 2022. That trial demonstrated accuracy for clinical SpO2 and heart rate that came in commensurate with FDA standards.
The company said clearance would make it the first consumer wearable to double as a medical device. Wearables already exist with FDA clearance for software that detects ECG and AFib, among other things. However, Movano said Evie feat…