Movano Health has received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. The company states this clearance unlocks potential applications in clinical trials, post-clinical trial management, and remote patient monitoring for 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.”
“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,” continued Mastrototaro. “We also remain excited about the opportunities to leverage our proprietary radio frequency (RF) technology to address cuffless blood pressure and noninvasive glucose monitoring.”
