Movano Health, a wearable technology company focused on women’s health, recently announced significant progress in the development of its Evie Med Ring. The company submitted its updated clinical trial results to the FDA as part of its 510(k) filing for this wearable pulse oximeter.
Notably, the latest study demonstrated that the Evie Med Ring’s accuracy in measuring blood oxygen saturation (SpO2) exceeds FDA guidelines across all skin tones, an achievement that positions the device for potential FDA clearance as a medical-grade biometric monitor.
“From the outset, our vision has been to develop a wearable that fits with any lifestyle and is cleared by the FDA as a medical device,” said John Mastrototaro, CEO of Movano Health. “The exemplary results of our latest study are a critical component of our FDA filing and lay the groundwork to fulfilling all aspects of that goal,” he added.
Beyond the clinical milestone, Movano Health also secured a $24 million investment, including a strategic seed investment from a major medical device company. The infusion of this capital could potentially pave the way for both development and industry partnerships to integrate the Evie Med Ring into broader healthcare applications.
The Evie Med Ring aims to differentiate itself from other wellness trackers by combining medical-grade biometric monitoring with a suite of health and wellness metrics. In addition to SpO2 and pulse, the device will track activity, sleep, women’s health, and more, with the data it collects designed to provide actionable insights for both individuals and healthcare providers.
—
May 9, 2024 – by Tony Bitzionis
Follow Us