The patch-based cardioverter defibrillator is approved for use in patients with a temporary elevated risk of sudden cardiac arrest.
Element Science announced that its innovative Jewel Patch Wearable Cardioverter Defibrillator (Patch-WCD) has received US Food and Drug Administration (FDA) approval of its Premarket Approval (PMA) application.
This decision paves the way for the Jewel Patch-WCD to be used for US patients who have an elevated temporary risk of sudden cardiac arrest. The Jewel Patch-WCD received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking in January 2024.
The Jewel Patch-WCD is a water-resistant wearable cardioverter defibrillator designed to detect and treat life-threatening arrhythmias in patients with a temporary elevated risk for sudden cardiac arrest. The device continuously monitors a patient’s heart and treats specific life-threatening rhythms. It is designed for continued protection during normal daily activities, including showering, sleeping, and moderate exercise.
The Jewel Mobile App is designed to enable timely patient care by transmitting therapy information to the patient’s medical team in near real-time.
“The Jewel Patch-WCD is the culmination of a vision to give patients a life-saving device that seamlessly integrates into their daily lives. 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,” says Uday N. Kumar, MD, founder, president, and CEO of Element Science, in a release.
Christine Albert, MD, the Stephen R. Corday, MD, Distinguished Chair in Cardiology in the Smidt Heart Institute at Cedars-Sinai, adds in a release, “The Jewel marks a significant advancement in safeguarding high-risk patients from sudden cardiac arrest. Its cutting-edge design and technology address a critical gap in cardiac care.”
