Movano plans Response Submission to FDA for EvieMed final review

Movano (MOVE) plans to submit updated responses next week to all clarifying questions that it recently received from the FDA as part of the final phase of the company’s 510(k) application review. The company secured a positive resolution this summer after responding to initial FDA questions related to EvieMED’s wellness features and metrics and remains optimistic on EvieMED’s potential for 510(k) clearance. The EvieMED Ring is a wearable device designed to provide medical device functionality through its pulse oximetry feature, and also offer wellness metrics related to sleep, activity and logging of mood, energy and other characteristics.