Movano Health Secures FDA Clearance For Eviemed Ring

Movano Health has announced FDA 510(k) clearance for its EvieMED Ring, a smart wearable that tracks medical and wellness metrics like blood oxygen levels, heart rate, mood, sleep, and activity. With this clearance, the company plans to expand into clinical trials, remote patient monitoring, and post-clinical trial management. Movano is in talks with a major payor to launch a 2025 pilot study and with a global pharmaceutical company for use in upcoming trials. The ring is also being utilized in an MIT clinical trial on long COVID and chronic Lyme disease.

CEO John Mastrototaro called the clearance a significant milestone, stating, “This FDA clearance expands our reach to pharmaceutical companies, medical device manufacturers, and payors seeking accurate and comfortable health monitoring solutions.”

Movano, a publicly traded company since March 2021, currently trades on the NYSE at approximately $5.52 per share. The company also offers the Evie Ring, a smart ring tailored for women with an open design for various finger sizes and an app that tracks health and wellness patterns, including menstrual cycles, sleep, and heart health. Earlier supply chain issues led to a temporary pause in availability, but the ring relaunched in September with an AI-powered app for personalized health insights.

In October, Movano investigated trading irregularities following shareholder approval of a 1-for-15 reverse stock split. The investigation revealed attempts to exploit the split, which were identified before any shares were rounded up.

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