Summary: Movano Health is moving forward in the final phase of its FDA 510(k) application for the EvieMED Ring, a wearable device that combines medical and wellness metrics. After addressing initial FDA questions about the device’s features, the company now plans to submit updated responses to additional clarifying questions from the agency. Movano remains optimistic that the EvieMED Ring will receive clearance, highlighting its potential for enhancing remote patient monitoring and data collection in clinical trials.
Three Key Takeaways:
- Final FDA Steps for EvieMED: Movano Health is preparing to submit responses to the FDA as part of the 510(k) review process, bringing the EvieMED Ring closer to potential clearance.
- Innovative Wearable Device: The EvieMED Ring combines pulse oximetry with wellness metrics such as sleep, activity, and mood tracking, aiming to support clinical trials and patient monitoring.
- Optimism for Approval: Movano Health’s leadership remains confident that EvieMED will achieve FDA clearance, positioning it as a valuable tool in patient compliance and health data collection.
Movano Health, which is pursuing regulatory clearance for its EvieMED Ring, announced that it plans to submit updated responses next week to all clarifying questions that it recently received from the US Food and Drug Administration (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.
“We are pleased that we will be submitting a timely and thorough response to the agency’s questions and look forward to the successful completion of the 510(k) review process,” says John Mastrototaro, president and CEO of Movano Health, in a release. “We believe EvieMED will be a game-changing device for our partners in remote patient monitoring and clinical trials, as they look for a consumer-friendly solution to bolster patient compliance and better data collection.”
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.
Photo caption: EvieMED Ring
Photo credit: Movano Health
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