Movano Health (Nasdaq: MOVE) has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter feature in its EvieMED Ring. This clearance allows Movano Health to pursue business opportunities for health monitoring solutions, including clinical trials, post-clinical trial management, and remote patient monitoring.
John Mastrototaro, President and CEO of Movano Health, stated that this clearance marks a significant milestone for the company, expanding its reach to pharmaceutical companies, medical device manufacturers, and payors. The EvieMED Ring aims to provide a more accurate, consistent, and comfortable health monitoring solution that integrates into patient lifestyles.
Collaborations and Studies
In anticipation of the clearance, Movano Health has been collaborating with potential partners across the healthcare industry. The company is in the agreement phase with a large payor for a pilot study planned for early 2025, focusing on health management of high-risk populations. Discussions are also underway with a global pharmaceutical company and a clinical research organization (CRO) for using the EvieMED Ring in upcoming clinical trials. Additionally, the ring has been selected for a study at MIT on long COVID and chronic Lyme disease.
Features and Benefits
The EvieMED Ring measures blood oxygen (SpO2) levels and heart rate. Traditional pulse oximeters can be uncomfortable, leading to poor compliance. The EvieMED Ring combines the accuracy of a medical device with the comfort of a wearable, designed to be worn continuously. A study also found that the EvieMED Ring provides accurate readings among users with darker skin tones, as measured by the Fitzpatrick scale.
In addition to pulse oximetry, the EvieMED Ring collects wellness metrics such as sleep, activity, temperature variability, calories burned, and respiration rate, providing a comprehensive view of the user's overall wellness. The ring will be available in eight sizes, ranging from 5 to 12.
Future Developments
Movano Health plans to continue collaborating with the FDA to secure additional clearances, including respiration rate and other critical analytes and diagnoses. The company is also exploring the use of its proprietary radio frequency (RF) technology for cuffless blood pressure and noninvasive glucose monitoring.
