Movano submits smart ring for pulse oximetry to FDA

The Evie smart ring. [Image courtesy of Movano Health]Movano Health (Nasdaq:MOVE) announced today that it submitted a 510(k) premarket notification to the FDA for its Evie Ring.

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 …

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  • August 3, 2023
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Movano unveils medical-grade smart ring for women’s health

The Evie smart ring. [Image courtesy of Movano Health]Movano Health (Nasdaq:MOVE) announced today that it unveiled its Evie smart ring designed specifically for women.

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…

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  • December 28, 2022
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