Element Sciences earns FDA premarket approval for wearable defibrillator patch

Element Science announced today that it received FDA pre-market approval for its Jewel Patch wearable cardioverter defibrillator (WCD).

San Francisco-based Element Science can now bring the Jewel Patch-WCD to U.S. patients with an elevated temporary risk of sudden cardiac arrest. This follows CE mark approval for the system in Europe in January 2024. The company says continued approvals help revolutionize the approach to live-saving wearable therapeutics.

Jewel Patch-WCD “introduces a paradigm shift in wearable cardiac defibrillation,” the company said in a news release. It combines a human-centered design with significant advancements in machine learning. Features include water resistance and a discreet profile. Element Science also developed a sophisticated algorithm to accompany a user-friendly design, it says.

The device continuously monitors a patient’s heart and treats specific life-threatening rhythms. Element Science designed it for continued protection during normal daily activities. It also has a companion mobile app to enable timely patient care by transmitting therapy information to the patient’s medical team in near-real-time.

Sign up for Blog Updates