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Evie Ring's Pulse Oximeter Exceeds FDA Accuracy Guidelines in Movano Health's Second Hypoxia Trial
PLEASANTON, Calif., March 14, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, has completed another hypoxia trial with the
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[{"type":"text","content":"PLEASANTON, Calif., March 14, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, has completed another hypoxia trial with the University of California, San Francisco (UCSF) yielding new blood oxygen saturation (SpO2) data, confirming the accuracy of its Evie Ring pulse oximeter exceeds the U.S. Food and Drug Administration (FDA) guidelines.\n\n \n \n \n \n \n \n\n \nThe Evie Ring entered commercial production in late 2023 as a consumer wellness device. This latest UCSF study, completed in the first quarter of 2024, used the production model ring, which reflected several design improvements from the pre-commercial model used in the earlier study and will be submitted to FDA and sold under the brand name Evie Med. During the second trial, each subject wore four Evie Rings. When testing arterial blood gas levels, the four Evie Rings achieved a root mean square error (RMSE) average of 2.46%, which was once again well below the FDA guidance of 3.5% for SpO2. Additionally, the Evie Ring's accuracy exceeded that of the two commercially available, hospital-grade reference pulse oximeters in the study.\nMovano Health believes one of the most critical components of the FDA submission remains the ring's clinical performance. The company plans to address the outstanding FDA comments from August 2023 for the Evie Med Ring in April 2024 and present the corroborating data from the first quarter of 2024 clinical study. Movano Health expects to receive a decision regarding its 510(k) clearance in July 2024.\n\"Our goal for Evie is to deliver both a consumer and medical device wearable that combines accessibility, personalization and style with the recognized capabilities of a medical device,\" said John Mastrototaro, CEO of Movano Health. \"The results of this latest study lay the groundwork to fulfilling all aspects of that goal. The journey toward establishing ourselves as a medical device company demands considerable effort, yet we view it as a substantial competitive advantage and a valuable asset in comparison to existing wellness solutions. We look forward to continuing to work closely with the FDA throughout this final step in the review process.\"\nThe Evie Ring combines health and wellness metrics to give a full picture of one's health: resting heart rate, heart rate variability, SpO2, respiration rate, s...