The clearance enables Movano Health to pursue multi-billion dollar business opportunities for health monitoring solutions needed for applications such as clinical trials, post-clinical trial management, and remote patient monitoring for both healthcare providers and payors.

“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.”

In anticipation of an expected 510(k) clearance, Movano Health has been collaborating with a number of potential partners operating across the entire healthcare industry spectrum and expects its partner pipeline to expand further following the news of a clearance. The Company is currently in the agreement phase with a large payor for a pilot study with the EvieMED Ring planned for early 2025 related to the health management of high-risk populations and is also in discussions with a global pharmaceutical company and leading clinical research organization (CRO) to use the EvieMED Ring in upcoming clinical trials. In addition, the EvieMED Ring was recently selected for a groundbreaking MIT study on long COVID and chronic Lyme disease.