Summary: Movano Health’s EvieMED Ring received FDA 510(k) clearance for its pulse oximeter, enabling expansion into clinical markets. The device aims to improve monitoring compliance by offering accurate, comfortable continuous wear, supporting clinical trials, remote monitoring, and high-risk patient management. Future enhancements include additional clearances and advanced RF-based measurements.
Key Takeaways:
- FDA clearance allows EvieMED Ring to transition from consumer-focused wearable to a clinically validated health monitoring solution for healthcare providers, payors, and researchers.
- Its comfort-focused design and comprehensive wellness metrics enhance patient compliance and provide valuable, accurate data that support better-informed healthcare decisions.
Movano Health announced U.S. Food and Drug Administration (FDA) 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,” 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.”
Collaborations and Future Partnerships
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 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,” said 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.”
Comfort and Compliance in Health Monitoring
Pulse oximeters measure blood oxygen (SpO2) levels and heart rate, but conventional solutions have shortcomings and can be uncomfortable, according to Movano, discouraging compliance that is needed to ensure reliable information for evaluating a patient’s health. 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 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.
