Movano Health (Nasdaq:MOVE) has announced securing FDA 510(k) approval for the pulse oximetry function within its EvieMED Ring. This clearance paves the way for Movano to explore further opportunities in health monitoring solutions, targeting applications like clinical trials, post-trial management, and remote patient monitoring for healthcare providers and insurers, according to a company news release.
Operating out of Pleasanton, California, Movano has proactively engaged potential collaborators in anticipation of the FDA’s decision. These partners cover the full spectrum of the healthcare industry, with the company expecting increased interest following the recent clearance. Currently, Movano is finalizing an agreement with a major insurer for a pilot program involving the EvieMED Ring set for early 2025, focusing on health management for high-risk groups.
Furthermore, Movano is in ongoing discussions with an international pharmaceutical company and a prominent clinical research organization about implementing the EvieMED Ring in forthcoming trials. Additionally, the ring has been chosen for an MIT study on long COVID and chronic Lyme disease.
According to Movano, EvieMED unites medical-grade accuracy with the ease of a continuous wearable device. It is designed with a small gap in the ring’s structure and a slight flex to accommodate finger swelling. A key study demonstrated the ring’s capability to provide reliable readings across users with various skin tones.
Beyond pulse oximetry, the EvieMED Ring tracks numerous wellness metrics such as sleep patterns, physical activity, temperature changes, calories expended, and breathing rates.
“Our initial introduction of the Evie Ring was in the consumer wearable sector, but our primary aim has always been to deliver a clinical-grade device for B2B applications,” stated John Mastrototaro, Movano Health’s president and CEO. “This FDA 510(k) approval signifies a significant breakthrough for the company, allowing us to reach pharmaceutical firms, medical device producers, and insurers seeking a more precise, consistent, and comfortable health monitoring tool that encourages user compliance by seamlessly integrating into their lifestyle.
“This milestone signals the start of our intention to intensify EvieMED’s market penetration. With the essential groundwork for our first clearance behind us, we are keen to continue partnering with the FDA on obtaining additional approvals, including those for respiration rate and other vital analytes and diagnostics. We also look forward to capitalizing on our exclusive radio frequency (RF) technology to tackle non-invasive blood pressure and glucose monitoring.”