Movano Health has received US FDA 510(k) clearance for the pulse oximeter in its EvieMed Ring.

The clearance enables the Californian company to pursue multi-billion-dollar business opportunities for health monitoring needed for applications such as clinical trials, post-clinical trial management and remote patient monitoring for healthcare providers and payers.

“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, 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 payers looking for more accurate, consistent and comfortable health monitoring that would help improve compliance by fitting easily into patient lifestyles.”

In anticipation of 510(k) clearance, Movano has been collaborating with potential partners operating across the entire healthcare industry spectrum and expects its partner pipeline to expand further following the news of clearance. The company is in the agreement phase with a large payer 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 organisation to use the ring in upcoming clinical trials. In addition, the 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,” said Mastrototaro. “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. We also remain excited about the opportunities to leverage our proprietary RF technology to address cuffless blood pressure and non-invasive glucose monitoring.”

Pulse oximeters measure blood oxygen (SpO₂) levels and heart rate, but conventional products have shortcomings and can be uncomfortable, discouraging compliance that is needed to ensure reliable information for evaluating a patient’s health. The EvieMed Ring eliminates those limitations by combining 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 the ring produces accurate readings among users with darker skin tones as measured by the Fitzpatrick scale of skin colour classification.

In addition, the ring collects wellness metrics including sleep, activity, temperature variability, calories burned and respiration rate that can give patients and healthcare providers a broader picture of the user’s overall wellness.

Founded in 2018, Movano Health (movanohealth.com) is developing a suite of purpose-driven healthcare products to bring medical-grade data to the forefront of wearables. Featuring modern and flexible form factors, the devices offer an innovative approach to delivering trusted data, capturing a comprehensive picture of an individual’s health data and translating it into personalised and intelligent insights.