On Dec. 2, 2024, Movano Health announced FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring.
About the EvieMED Ring
The EvieMED Ring is a finger wearable device featuring a small gap in the ring surface and slight flex to accommodate finger swelling. The ring is designed for continuous wear. It collects wellness metrics including heart rate, SpO2, sleep, activity, temperature variability, calories burned and respiration rate.
According to the company’s press release, one study found that the EvieMED Ring produces accurate readings among users with darker skin tones, as measured by the Fitzpatrick scale of skin color classification.
This FDA clearance enables the EvieMED Ring to be used in clinical trials, post-clinical trial management and remote patient monitoring.
The EvieMED Ring is Movano’s FDA-cleared B2B product, complementing the Evie Ring, a direct-to-consumer medical-grade health wearable designed for women.
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