Movano secures clearance for pulse ox 

PLEASANTON, Calif. – Movano Health has announced U.S. Food and Drug Administration 510(k) clearance for the pulse oximeter in its EvieMED Ring. The company says the clearance enables it 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 health care providers and payers. "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." Movano Health is currently in the agreement phase with a large payer 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 to use the EvieMED Ring in upcoming clinical trials. In addition, the company says the EvieMED Ring was recently selected for an MIT study on long COVID and chronic Lyme disease. "This milestone marks the beginning of our plans to accelerate distribution of EvieMED,” Mastrototaro said. “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 technology to address cuffless blood pressure and noninvasive glucose monitoring."