#United States #FDA Clearance #Pleasanton #Movano Health #EvieMED Ring

Movano Health Achieves FDA Clearance for EvieMED Ring

Movano Health, a trailblazer in health technology, recently announced a significant milestone: the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's innovative EvieMED Ring. With this approval, Movano is set to unlock a remarkable $40 billion total addressable market in the healthcare B2B sector, creating new avenues for its health monitoring solutions.

The EvieMED Ring, which features a built-in pulse oximeter, represents a leap forward in medical wearable technology. It is uniquely designed for applications ranging from clinical trials to remote patient monitoring. As John Mastrototaro, President and CEO of Movano Health, notes, while they initially launched the Evie Ring in the consumer market, their long-term vision has always been to develop a clinical-grade device suitable for various B2B applications. This clearance is thus a pivotal step in expanding their reach to pharmaceutical companies and healthcare payors.

Movano Health has actively collaborated with multiple stakeholders across the healthcare industry in anticipation of this clearance. The company is currently negotiating agreements with major payors for pilot studies utilizing the EvieMED Ring, scheduled to take off in early 2025 for high-risk populations. Furthermore, discussions are underway with a leading global pharmaceutical company and a prominent clinical research organization (CRO) to deploy the EvieMED Ring in upcoming clinical trials. This ring has also been selected for an innovative study at MIT focusing on long COVID and chronic Lyme disease, showcasing its versatile potential.

The EvieMED Ring is not merely a pulse oximeter; it aims to redefine patient compliance. Traditional solutions often present issues of discomfort that can hinder consistent use. In contrast, the EvieMED Ring blends the precision of medical-grade devices with the comfort of modern wearables, making it possible for users to wear it around the clock. It features a cleverly designed flexible form that accommodates finger swelling, addressing a common problem in traditional medical devices.

One notable study confirms that the EvieMED Ring provides accurate readings across a diverse population, including individuals with darker skin tones—a critical factor in ensuring health equity and effective patient monitoring. In addition to measuring SpO2 levels and heart rates, the EvieMED Ring captures various wellness metrics, including sleep quality, activity levels, temperature variability, calories burned, and respiration rates, presenting a comprehensive view of an individual’s overall health.

Available in eight different sizes from 5 to 12, the ring caters to a broad demographic, ensuring its usability across various patient profiles. Movano Health is committed to not only improving health monitoring but also making it accessible and comfortable for everyday users.

Looking ahead, Movano Health is optimistic about securing additional FDA clearances that could enable new features, including respiration rate and non-invasive glucose monitoring. Furthermore, the company is excited about its proprietary radio frequency technology, aiming to address cuffless blood pressure measurement among other innovations.

Founded in 2018, Movano Health (Nasdaq: MOVE) is dedicated to pushing the boundaries of health technology. By merging state-of-the-art design with practical medical applications, Movano is leading the charge towards a future where health monitoring seamlessly integrates into daily life, helping to improve health outcomes across a myriad of patient populations.

For more information, visit Movano Health's website.