What You Should Know:
– Movano Health, a health technology innovator, has achieved a significant milestone with the FDA 510(k) clearance of the pulse oximeter integrated into its Evie Ring.
– The FDA clearance paves the way for Movano to pursue new opportunities in health monitoring solutions, including clinical trials, post-clinical management, and remote patient monitoring.
Addressing the Limitations of Traditional Pulse Oximeters
Traditional pulse oximeters can be uncomfortable and inconvenient for continuous wear, hindering patient compliance and data accuracy. The Evie Ring overcomes these limitations by:
- Combining Accuracy and Comfort: Offers the accuracy of a medical-grade pulse oximeter in a comfortable and stylish wearable ring.
- Continuous Monitoring: Enables continuous monitoring of blood oxygen levels and heart rate, providing a more comprehensive view of patient health.
- Inclusive Design: Provides accurate readings for individuals with darker skin tones, addressing a critical need for equitable healthcare technology.
Comprehensive Health Monitoring
In addition to blood oxygen and heart rate, the Evie Ring tracks various wellness metrics, including sleep, activity, temperature variability, calories burned, and respiration rate. This comprehensive data provides valuable insights into a user’s overall health and well-being.
Partnerships and Future Opportunities
Movano Health has been actively collaborating with potential partners across the healthcare industry in anticipation of FDA clearance. The company is currently in discussions with:
- A large payor: For a pilot study using the Evie Ring for health management of high-risk populations.
- A global pharmaceutical company and CRO: To utilize the Evie Ring in upcoming clinical trials.
The Evie Ring has also been selected for a groundbreaking MIT study on long COVID and chronic Lyme disease.
”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.”
