It looks like Movano has its sights set on getting clearance from the U.S. Food and Drug Administration (FDA). And soon. The makers of the Movano Ring have conducted a study with researchers at the University of California San Francisco (UCSF) to gauge the wearable’s ability to measure blood oxygen saturation (SpO2) and heart rate. They say the study’s results exceed the industry standards that the FDA uses to evaluate SpO2 devices, prompting Movano to plan a larger study with the goal of FDA submission later this year.
The initial study is admittedly small in scale; seven subjects wore Movano Ring prototypes and had reference measuring devices to serve as controls for comparison. To create conditions similar to mild, moderate, and severe hypoxia, the oxygen levels of the participants were brought down to as low as 70% and then raised to 100%. During this shift, Movano Ring prototypes measured heart rates that ranged from 60 to 120 beats per minute. Compared to data collected by the reference devices, the Movano Ring had a 2% margin of error, according to the study. The FDA’s requirement for SpO2 measuring is a 4% margin.
While the ring used in the study has yet to hit the consumer market, its makers have given us a glimpse of what the Movano Ring can do. Beyond heart rate and blood oxygen, the wearable measures steps, calories, respiration, and body temperature, offering a range of sleep metrics designed to give the wearer the best possible night’s slumber. The Movano app also gives insights into chronic illnesses such as diabetes. And the company has one particular niche market in mind: women wishing to conceive. As Movano puts it, “It will let you know if your body temperature goes up (so find your partner if you’re trying to conceive!).”
Movano says it expects its ring to be “one of the most affordable health devices on the market.” But we’re not there yet. Movano CEO John Mastrototaro says, “This hypoxia study is a promising display of the quality metrics our ring can deliver…[but just] an exciting step toward the FDA submission.”