Summary: Movano Health had an in-person meeting with the US Food and Drug Administration (FDA) on Aug 15 to discuss the wellness features of its EvieMED Ring. The meeting resulted in the advancement of the review process for the device, which includes both medical and wellness functionalities.
Key Takeaways:
- Advancement in FDA Review: Movano Health’s in-person meeting with the FDA has moved the review process for the EvieMED Ring forward.
- Ongoing 510(k) Clearance Efforts: The company remains focused on obtaining 510(k) clearance for the EvieMED Ring’s pulse oximetry function, having addressed additional questions from the FDA during the review process.
- Upcoming Product Relaunch: Movano Health plans to reopen direct-to-consumer orders for the Evie Ring on Sept 17, incorporating new enhancements in sleep tracking, activity monitoring, and overall device functionality.
Movano Health announced that an in-person meeting with the US Food and Drug Administration (FDA) on Aug 15 resulted in a positive outcome regarding the EvieMED Ring’s wellness features and metrics.
Following this development, the company will be working with the agency to move forward with the 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 numerous wellness metrics related to sleep, activity, and logging of mood, energy, and other characteristics.
“We are pleased that we have been able to work collaboratively with the FDA as we continue to seek a 510(k) clearance for EvieMED,” says John Mastrototaro, president and CEO of Movano Health, in a release. “With a positive resolution to the ring’s wellness features in hand, we look forward to completing the final review of our submission.”
Updated FDA Clearance Application
On April 21, Movano Health filed an updated 510(k) clearance application for the EvieMED Ring’s pulse oximetry feature. 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 response. The in-person meeting with the FDA was held on Aug 15.
Separately, Movano Health recently announced that it will begin taking direct-to-consumer orders again for the Evie Ring on Sept 17. The expanded launch will incorporate several product enhancements across sleep, activity, and insights, as well as improved operations processes.
Photo caption: Evie Ring
File photo
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