Movano Health announced it received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. Clearance enables Movano to pursue new opportunities for health monitoring solutions needed for applications like clinical trials, post-clinical trial management and remote patient monitoring for both healthcare providers and payors, the company said in a news release.
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Pleasanton, California–based Movano said it had already begun collaborating with potential partners in anticipation of FDA clearance. Its potential partners operate across the entire healthcare industry spectrum and the company expects more following the FDA nod. Movano is currently in the agreement phase with a large payor for a pilot study with the EvieMED Ring planned for early 2025. The study covers health management for high-risk populations.
Additionally, Movano has discussions ongoing with a global pharmaceutical company and leading clinical research organization around using the EvieMED Ring in upcoming trials. An MIT study on long COVID and chronic Lyme disease also elected to use the EvieMED Ring.
EvieMED combines the accuracy of a medical device with the comfort of a continuous wearable, Movano says. It features a small gap in the ring surface and a slight flex to accommodate finger swelling. A pivotal study also found that the ring produces accurate readings among users with darker skin tones.
Additionally, the EvieMED Ring collects a range of wellness metrics. Those include sleep, activity, temperature variability, calories burned and respiration rate.
“We launched the Evie Ring in the consumer wearable market, but our broader goal has always been to provide a clinical-grade device for B2B channels,” said John Mastrototaro, president and CEO of Movano Health. “This FDA 510(k) clearance marks a major milestone for the company and expands our reach to pharmaceutical companies, medical device manufacturers and payors looking for a more accurate, consistent and comfortable health monitoring solution that would help improve compliance by fitting easily into patient lifestyles.
“This milestone marks the beginning of our plans to accelerate distribution of EvieMED. With the significant foundational work in achieving our first clearance now behind us, we are eager to continue to collaborate with the FDA on securing additional clearances including respiration rate and other critical analytes and diagnoses. We also remain excited about the opportunities to leverage our proprietary radio frequency (RF) technology to address cuffless blood pressure and noninvasive glucose monitoring.”
