FDA approves new AI-enabled wearable cardioverter defibrillator

Element Science, a California-based medtech company, has gained U.S. Food and Drug Administration (FDA) approval for its Jewel Patch Wearable Cardioverter Defibrillator (Patch-WCD) for patients with an elevated risk of sudden cardiac arrest. The device previously received both CE mark approval and UKCA mark approval in the U.K.

The Jewel Patch-WCD was designed to monitor patients for extended periods of time for signs of sudden cardiac arrest, delivering real-time data to their care teams. It can be worn for up to a week at a time, with no daily maintenance required, and was built to be both durable and resistant to water. The newly approved device also includes advanced artificial intelligence algorithms trained to minimize the risk of false alarms and inappropriate shocks.

“FDA approval represents more than a regulatory milestone. It’s a leap forward in how we, as clinicians, think about using cutting-edge therapeutic technology to empower patients to live their fullest lives, even when at risk of sudden cardiac arrest,” Uday N. Kumar, MD, founder, president and CEO of Element Science, said in a statement. “I have been a long-time believer in the idea that individuals using wearable innovations should feel like people, and not patients, and so we are proud to lead the transformation of care through devices like the Jewel Patch-WCD.”