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Movano Health Provides Update on FDA Review of EvieMED Ring
Movano Health (Nasdaq: MOVE) provided an update on the FDA review of its EvieMED Ring. The company received additional clarifying questions from the FDA related to medical aspects of the device, as part of the final phase of its 510(k) application review process. Movano Health remains optimistic about EvieMED's potential for 510(k) clearance after securing a positive resolution to initial FDA questions about wellness features and metrics.
The EvieMED Ring is designed to provide medical device functionality through pulse oximetry, along with wellness metrics for sleep, activity, and mood tracking. Separately, Movano Health successfully resumed direct-to-consumer orders for the Evie Ring on September 17, 2024, with initial positive response to product and operational improvements.
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