Movano Health announced today that it received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. Clearance enables Movano to pursue for health monitoring solutions needed for applications like clinical trials, post-clinical trial management and remote patient monitoring for both healthcare providers and payors.
EvieMED combines the accuracy of a medical device with the comfort of a continuous wearable. It features a small gap in the ring surface and a slight flex to accommodate finger swelling. A pivotal study also found that the ring produces accurate readings among users with darker skin tones. The EvieMED Ring collects a range of wellness metrics. Those include sleep, activity, temperature variability, calories burned and respiration rate.
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