Summary: Movano Health, which is pursuing FDA clearance for its EvieMED Ring, recently received additional clarifying questions from the FDA regarding the medical aspects of the device. This marks the final phase of the company’s 510(k) application review process. Movano says it secured a positive outcome from earlier FDA questions related to the wellness features of the EvieMED Ring and remains confident in addressing the latest inquiries. Separately, Movano has resumed taking direct-to-consumer orders for its Evie Ring.
Key Takeaways:
- FDA Clarifying Questions: Movano Health received additional clarifying questions from the FDA concerning the medical functionality of the EvieMED Ring, marking the final phase of the 510(k) review process.
- Positive Progress: The company had successfully addressed earlier questions regarding the wellness features of the EvieMED Ring and remains optimistic about obtaining FDA clearance.
- Direct Sales Resumed: Movano Health has resumed direct-to-consumer orders for its Evie Ring, with enhancements in sleep, heart rate, and activity monitoring, as well as improved customer service.
Movano Health, which is pursuing US Food and Drug Administration (FDA) clearance for its EvieMED Ring, announced that it recently received additional clarifying questions from the FDA related to medical aspects of the device as part of the final phase of the company’s 510(k) application review process.
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 FDA 510(k) clearance process is a rigorous one, and we are pleased with the progress we continue to make,” says John Mastrototaro, president and CEO of Movano Health, in a release. “We are confident we can effectively address the follow-up questions that the agency has submitted, and we look forward to completing the final review of the EvieMED Ring.”
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.
Evie Ring Restock
Separately, Movano Health announced that it commenced taking direct-to-consumer orders again for the Evie Ring on Sept 17, 2024. The ring was relaunched with key upgrades, including improved sleep data accuracy.
The company notes in a release that it is “pleased with the initial response to product and operational improvements, including enhanced sleep, heart rate, and activity monitoring, expanded AI-generated personalized insights, and upgrades across manufacturing, logistics, and customer service.”
Photo caption: Evie Ring
Photo credit: Movano Health/file photo
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