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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
About this update from Corvex, Inc.
[{"type":"text","content":"A successful response to requests for additional information would bring the Company one step closer to introducing this pioneering healthcare product to the market\nPLEASANTON, 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.\n\n \n \n \n \n \n \n\n \n\"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.\"\nThe 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. \nAbout 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.\nMovano 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/.\nForward Looking StatementsThis press release contains forward-looking statements concer...