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Movano Health On Track to File First FDA Submission for its Smart Ring’s SpO2 and Heart Rate Data Following Successful Pivotal Hypoxia Trial
December 16, 2022
Movano Health, a purpose-driven healthcare solutions company at the intersection of medical and consumer devices, today announces successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the University of California, San Francisco (UCSF) to assess the accuracy of its smart ring’s blood oxygen saturation (SpO2) and heart rate data. In comparing the overall accuracy of the ring’s data with data from the study’s reference devices, Movano Health’s ring resulted in an approximate 2% margin of error, well below the FDA consensus standard of 4% for SpO2. Additionally, the Company’s device measured heart rate that had root mean square error of approximately 2 BPM, which is also in line with the FDA’s requirements. Given these positive results, Movano Health expects to file for FDA clearance of these metrics in 2023.
Following a successful pilot study in July 2022, the latest study used the same protocol required by the FDA for the submission and involved 11 subjects of mixed genders and ethnicities. The participants, the majority of whom were between IV-VI, the darker skin tones on the Fitzpatrick scale, each wore a ring prototype, a Movano Health fingertip device and two reference devices. Within a controlled environment, each participant’s oxygen levels were driven down to as low as 70 percent and then back up to 100 percent to test the accuracy of Movano Health’s devices over the entire range of oxygen saturation including normal, mild, moderate and severe hypoxia. Movano Health device data was compared and validated by arterial blood gas data.
“Our company is deeply committed to developing wearable devices that go beyond the status quo and give all consumers, regardless of gender and ethnicity, a higher level of confidence and trust in their health data. FDA approval remains one of the top priorities for our smart ring and the outstanding preliminary results we received from our pivotal study are extremely exciting,” said John Mastrototaro, CEO of Movano Health. “Clearance of a wearable device requires extensive investment in research and development, and it has been a central goal of ours since the beginning. Providing medical-grade heart rate and SpO2 data in the future will position us to help users better predict, prevent and understand health issues.”
For more information on Movano Health, visit www.movanohealth.com.
About Movano Health
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, visit www.movanohealth.com.
See Full Press Release at the Source: Movano Health On Track to File First FDA Submission for its Smart Ring’s SpO2 and Heart Rate Data Following Successful Pivotal Hypoxia Trial
Press Release by: Movano Health
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