Movano Health has completed another hypoxia trial yielding new blood oxygen saturation (SpO2) data that show the accuracy of its Evie Ring pulse oximeter exceeds the US Food and Drug Administration (FDA) guidelines.
The Evie Ring entered commercial production in late 2023 as a consumer wellness device. This latest study, conducted with the University of California, San Francisco, used the production model ring, which reflected several design improvements from the pre-commercial model used in an earlier study. It 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 average of 2.46%, which was 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.
Movano 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 this clinical study. Movano Health expects to receive a decision regarding its 510(k) clearance in July 2024.
“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,” says John Mastrototaro, CEO of Movano Health, in a release. “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.”
The Evie Ring delivers health and wellness metrics, including resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile—including steps, active minutes, and calories burned—sleep stages and duration, and mood tracking. This data is delivered through a mobile app.
Photo caption: Evie Ring
Photo credit: Movano Health
