Movano Health Plans Response Submission to FDA Next Week as Part of EvieMED Final Review Phase
A successful response to requests for additional information would bring the Company one step closer to introducing this pioneering healthcare product to the market
PLEASANTON, Calif., Oct. 24, 2024 /PRNewswire/ — Movano Health (Nasdaq: MOVE) announced today that it plans to submit updated responses next week to all clarifying questions that it recently received from the 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,” said John Mastrototaro, President and CEO of Movano Health. “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.
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
