Movano’s Evie Ring pulse oximeter exceeds FDA accuracy guidelines

Movano Health has completed another hypoxia trial with the University of California, San Francisco yielding new blood oxygen saturation data, confirming the accuracy of its Evie Ring pulse oximeter exceeds the FDA guidelines. The Evie Ring entered commercial production in late 2023 as a consumer wellness device. This latest UCSF study, completed in Q1, 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, the four Evie Rings achieved a root mean square error 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. 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 Q1 clinical study. Movano Health expects to receive a decision regarding its 510(k) clearance in July.