Movano Health has secured FDA clearance for the pulse oximeter in the EvieMED Ring.
RT’s Three Key Takeaways
- FDA Clearance Expands Clinical Applications: The 510(k) clearance enables the EvieMED Ring to be used in clinical trials, remote patient monitoring, and health management for high-risk populations.
- Focus on Inclusivity and Wearable Comfort: The EvieMED Ring offers pulse oximeter readings across skin tones and features a flexible design for continuous wear.
- Future Development Plans: Movano Health aims to secure further FDA clearances for additional metrics, including respiration rate, cuffless blood pressure, and noninvasive glucose monitoring.
Movano Health announced the US Food and Drug Administration (FDA) granted 510(k) clearance for the pulse oximeter in its EvieMED Ring.
The clearance enables Movano Health to pursue 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,” says John Mastrototaro, president and CEO of Movano Health, in a release. “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.”
Broadening Clinical Applications
In anticipation of an expected 510(k) clearance, Movano Health has been collaborating with potential partners across the healthcare industry and expects its partner pipeline to expand further following the news of a clearance.Â
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 to use the EvieMED Ring in upcoming clinical trials, according to a release from the comapny. In addition, 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. 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,” says Mastrototaro in a release. “We also remain excited about the opportunities to leverage our proprietary radio frequency technology to address cuffless blood pressure and noninvasive glucose monitoring.”
A Device Designed for Wearability and Accuracy
Movano Health notes in a release that the EvieMED Ring combines the accuracy of a medical device with the comfort of a wearable that can be worn continuously, thanks in part to a design with a small gap in the ring surface and slight flex that accommodates finger swelling. A pivotal study also found that the EvieMED Ring produces accurate readings among users with darker skin tones as measured by the Fitzpatrick scale of skin color classification.
In addition, the EvieMED Ring collects wellness metrics, including sleep, activity, temperature variability, calories burned, and respiration rate, that can give both patients and healthcare providers a broader picture of the user’s overall wellness.
The EvieMED Ring will be available in eight sizes ranging from 5 to 12 to accommodate the widest selection of patients.
Photo caption: Evie ring
File photo/Movano Health
