Movano Health said it plans to meet with the FDA in mid-August, as part of the company's ongoing process to secure a 510(k) clearance for the EvieMED Ring, a wearable designed to not only provide medical device functionality through its pulse oximetry feature, but also offer numerous wellness metrics related to sleep, activity and mood/energy/symptom logging. On April 21, 2024, Movano Health filed an updated 510(k) for the EvieMED Ring's pulse oximetry feature. At the time of the filing and based on prior interactions with the agency and its protocols, the company indicated it could potentially receive a regulatory decision by July 2024.
Subsequent to the filing, in May and early June, two minor clarifications were requested by the FDA review team and promptly completed by Movano Health. In late June, the FDA review team requested additional information related to the wellness aspects of EvieMED. In conjunction with the company's regulatory advisors, Movano Health provided a draft response to the FDA's questions on July 10, 2024, and requested a meeting with the agency to review the Company's draft response. Given the FDA's internal calendar, the agency has since scheduled the meeting with the Company for mid-August. Movano Health looks forward to meeting with the FDA and working towards resolving the matter related to the inclusion of EvieMED's wellness aspects in order to move forward with the review process.
"Although we understand that 510(k) regulatory review timelines can vary based on the agency's summer calendar, we remain steadfast in our commitment to the opportunity EvieMED could unlock, given the clinical evidence provided as part of the filing related to the pulse oximetry feature and our desire to work collaboratively with the agency," said John Mastrototaro, CEO and President of Movano Health.
