Movano Health, Pleasanton, CA, has announced 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 percent margin of error, well below the FDA consensus standard of 4 percent 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,” says 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.”