The 510(k) application covers Evie Ring’s pulse oximeter that includes heart rate and SpO2 data, and is expected to make it one of the first consumer wearables that is also cleared for clinical use
Today, Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Company’s first commercial product, the Evie Ring. The submission has passed the first milestone of the review process, an initial review for completeness, and is now under full review by the FDA.
One of the most critical components of the FDA submission is the ring’s clinical performance. In Q4 2022, Movano Health completed a successful pivotal hypoxia trial with the University of California, San Francisco (UCSF) to assess the accuracy of Evie’s blood oxygen saturation (SpO2). In comparing the overall accuracy of the ring’s data with data from arterial blood gas data, the Evie Ring achieved an approximate 2% margin of error, well below the FDA guidance of 3.5% for SpO2. In a separate nonclinical test completed by Movano Health per the standard and FDA guidance, pulse was tested over the range of 40 to 240 beats per minute (BPM) and the Evie Ring margin of error was 1 BPM, also exceeding FDA’s requirements.
“From the outset, our vision for Evie has been to develop a consumer wearable that is beautiful, accessible and personalized, as well as be cleared by the FDA as a medical device. This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings,” said John Mastrototaro, CEO of Movano Health. “The effort associated with becoming a medical device company is certainly significant, but we believe it’s a highly competitive differentiator and a strong asset when compared to existing wellness solutions. It also is expected to enable significant partnership opportunities with healthcare and other enterprises. We look forward to working with the FDA through the review process.”
The Evie Ring combines health and wellness metrics to give a full picture of one’s health: resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. This data is delivered through a mobile app which aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric data into actionable insights that will help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease.
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health is developing a suite of purpose-driven healthcare solutions to bring medical-grade, high-quality data to the forefront of consumer health devices. Featuring modern form factors, Movano Health’s devices capture a comprehensive picture of a person’s vital health information and uniquely translate the data into personalized and intelligent insights that empower consumers to live healthier and more balanced lives. Movano Health’s end-to-end solutions will soon enable consumers, caretakers, and healthcare professionals to utilize daily medical-grade data as a tool to proactively monitor and manage their health. 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 anticipated FDA clearance for the Evie Ring, expected future operating results; product development and features, product releases, clinical trial, 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.
The information stated above was prepared by Movano Health and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of Movano Health, or any of its products, by The Regents of the University of California, its officers, agents and employees.
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