Movano Provides Update on EvieMED Ring’s FDA Review Process

Summary: Movano Health has submitted a complete response to the FDA as part of the final review phase of its 510(k) application for the EvieMED Ring, a wearable device that combines medical functionality, such as pulse oximetry, with wellness tracking features. Movano remains optimistic about achieving 510(k) clearance, which would enable broader applications for remote patient monitoring and clinical trials.

Key Takeaways:

1. Final Review Stage for FDA 510(k) Clearance: Movano is in the final phase of the 510(k) application review process for its EvieMED Ring.
2. Dual Focus on Medical and Wellness Features: The EvieMED Ring is designed to provide both medical-grade functions, like pulse oximetry, and wellness tracking, including sleep and activity metrics.
3. Potential for Expanded Use in Remote Monitoring: Movano views the EvieMED Ring as a valuable tool for remote patient monitoring and clinical trials, anticipating “game-changing opportunities” if FDA clearance is granted.

Movano Health has submitted a complete response package to the US Food and Drug Administration (FDA) as part of the final phase of the company’s 510(k) application review of the EvieMED Ring. 

The company says in a release that it “remains optimistic on EvieMED’s potential for 510(k) clearance.”

“Our team has worked diligently to provide a thorough response to the agency’s questions,” says John Mastrototaro, president and CEO of Movano Health, in a release. “We look forward to the successful completion of the 510(k) review process and continue to focus on the game-changing opportunities that we believe EvieMED could unlock for our partners in remote patient monitoring and clinical trials.”

Movano announced last month that the FDA had additional clarifying questions related to medical aspects of the device as part of the final phase of the company’s 510(k) application review process. 

The EvieMED Ring is a wearable device designed to not only provide medical device functionality through its pulse oximetry feature but also offer wellness metrics related to sleep, activity and logging of mood, energy, and other characteristics.

Photo caption: Evie ring

File photo/Movano Health

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