Movano Health Submits Response to FDA as Part of Final Review Phase for EvieMED

Rhea-AI Summary

Movano Health (NASDAQ: MOVE) has submitted a complete response package to the FDA for the final review phase of its 510(k) application for the EvieMED Ring. The company remains optimistic about receiving 510(k) clearance for this wearable device. The EvieMED Ring combines medical functionality through pulse oximetry with wellness tracking features, including sleep monitoring, activity tracking, and mood and energy logging capabilities. The company sees potential opportunities in remote patient monitoring and clinical trials markets.

Positive

• Device combines medical functionality with wellness tracking features
• Potential market opportunities in remote patient monitoring and clinical trials
• Progress in FDA 510(k) clearance process with submission of complete response package

Negative

• FDA clearance still pending and not guaranteed
• No revenue generation until regulatory approval and market launch

Insights

Medical Device Regulatory Expert

The FDA response submission for EvieMED Ring's 510(k) clearance represents a critical regulatory milestone. The device's dual functionality as both a medical device (pulse oximetry) and wellness tracker positions it uniquely in the wearable market. However, several factors warrant consideration:

• 510(k) responses typically receive FDA feedback within 90 days
• Pulse oximetry clearance requires demonstration of substantial equivalence to predicate devices
• The combined medical and wellness features may require careful regulatory positioning

While management expresses optimism, FDA clearance remains uncertain until final determination. The remote patient monitoring and clinical trials markets represent significant opportunities, but market entry depends entirely on successful regulatory clearance.

Company remains optimistic on the potential for this pioneering healthcare solution

PLEASANTON, Calif., Nov. 4, 2024 /PRNewswire/ -- Movano Health (NASDAQ: MOVE) announced today that it has submitted a complete response package to the FDA as part of the final phase of the Company's 510(k) application review of the EvieMED Ring. The Company remains optimistic on EvieMED's potential for 510(k) clearance.

"Our team has worked diligently to provide a thorough response to the Agency's questions," said John Mastrototaro, President and CEO of Movano Health. "We look forward to the successful completion of the 510(k) review process and continue to focus on the game changing opportunities that we believe EvieMED could unlock for our partners in remote patient monitoring and clinical trials."

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. 

About Movano Health
Founded in 2018, Movano Inc. (NASDAQ: MOVE) dba Movano Health, maker of the Evie Ring (www.eviering.com), is developing a suite of purpose-driven healthcare solutions to bring medical-grade data to the forefront of wearables. Featuring modern and flexible form factors, Movano Health's devices offer an innovative approach to delivering trusted data to both customers and enterprises, capturing a comprehensive picture of an individual's health data and uniquely translating it into personalized and intelligent insights.

Movano Health is developing its proprietary technologies and wearable medical device solutions to enable the future use of data as a tool to proactively monitor and manage health outcomes across a number of patient populations that exist in healthcare. For more information on Movano Health, visit https://movanohealth.com/.

Forward Looking Statements
This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding plans with respect to the commercial launches of the Evie Ring and EvieMED Ring; our expectations regarding potential commercial opportunities; planned cost-cutting initiatives; anticipated FDA clearance decisions with respect to our products; expected future operating results; product development and features, product releases, clinical trials and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors."  Any forward-looking statement in this release speaks only as of the date of this release. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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SOURCE Movano

FAQ

What features does the Movano Health EvieMED Ring (MOVE) offer?

The EvieMED Ring offers medical device functionality through pulse oximetry, along with wellness metrics tracking for sleep, activity, mood, and energy levels.

What is the current FDA approval status for Movano Health's EvieMED Ring (MOVE)?

Movano Health has submitted a complete response package to the FDA as part of the final phase of their 510(k) application review, with clearance pending.

What markets is Movano Health (MOVE) targeting with the EvieMED Ring?

Movano Health is targeting opportunities in remote patient monitoring and clinical trials markets with the EvieMED Ring.