Summary: Movano Health is working toward securing a 510(k) clearance from the FDA for its EvieMED Ring, a wearable device that combines medical functionality through pulse oximetry with wellness metrics related to sleep, activity, and mood/energy/symptom logging. After filing an updated 510(k) for the pulse oximetry feature in April, the company responded to minor clarifications and additional information requests from the FDA. A meeting with the FDA is scheduled for mid-August to review these responses and discuss the wellness aspects of the device.
Key Takeaways:
- Scheduled FDA Meeting: Movano Health is set to meet with the FDA in mid-August as part of its efforts to secure 510(k) clearance for the EvieMED Ring, which includes a pulse oximetry feature and wellness metrics.
- Regulatory Process Progress: The company has addressed minor clarifications and additional information requests from the FDA, indicating ongoing progress in the regulatory review process.
- Focus on Wellness Features: The FDA requested additional information related to the wellness aspects of the EvieMED Ring, which Movano Health is preparing to address in the upcoming meeting.
Commitment to Collaboration and Innovation: Movano Health emphasizes its commitment to working collaboratively with the FDA to unlock the potential of the EvieMED Ring, which integrates clinical evidence and innovative wellness features.
Movano Health plans to meet with the US Food and Drug Administration (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.
Progress in Regulatory Process
On April 21, 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.
Subsequent to the filing, in May and early June, two minor clarifications were requested by the FDA review team and 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 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.
Moving Forward with FDA Review
Movano Health notes in a release that it looks forward to meeting with the FDA and working toward 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,” says John Mastrototaro, CEO and President of Movano Health, in a release.
Photo caption: Evie Ring
File photo
Leave a Reply