“It is no small task to be a medical device company, build this infrastructure, build all the standard operating procedures that the FDA wants to see,” says Movano Health CEO John Mastrototaro, whose company is working on making an FDA-cleared smart ring for consumers.
When I caught up with Mastrototaro at this year’s CES, he wasn’t fazed much. Instead, he pointed to the fact that the ring — now called Evie, short for “evidence”— successfully passed a hypoxia trial in October 2022, showing clinical-level accuracy for heart rate and oxygen saturation measurements. The FDA, Mastrototaro says, requires accuracy across a broad range of oxygen levels with a margin of error of 4 percent. That has to be tested for women, men, and people of all skin tones.
But if successful, the Evie Ring would be one of the first consumer wearables fully cleared as a medical device.FDA clearance may also be the only way a company can get novel health tech into the hands of consumers. For the past, Valencell — a wearable tech provider to companies like LG, Jabra, and Bose — has been at CES showcasing its noninvasive blood pressure monitoring tech using photoplethysmography sensors.
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