FDA approves Jewel patch-wearable defibrillator

Jewel patch-wearable defibrillator: ©Jewel

The U.S. Food and Drug Administration has granted premarket approval to the Jewel Patch Wearable Cardioverter Defibrillator (Patch-WCD), a next-generation wearable device from Element Science designed to protect patients at temporary high risk for sudden cardiac arrest (SCA).

The FDA’s decision marks a major milestone for Element Science, which had already received regulatory clearance in Europe and the United Kingdom earlier this year. The Jewel Patch-WCD is now set to become widely available in the United States, offering new hope for patients in the critical window following cardiac events or surgeries that elevate their risk for SCA.

"The Jewel Patch-WCD is the culmination of a vision to give patients a life-saving device that seamlessly integrates into their daily lives," said Uday N. Kumar, founder and CEO of Element Science. "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."

Unlike traditional wearable defibrillators, which can be bulky and uncomfortable, the Jewel Patch-WCD is water resistant, discreet, and engineered with human-centered design principles. Its machine learning-based algorithm continuously monitors for life-threatening arrhythmias and can deliver therapy as needed, even while the patient is showering, sleeping, or exercising. The device also pairs with a mobile app that shares real-time data with a patient’s care team.

Cardiologist Christine Albert of the Smidt Heart Institute at Cedars-Sinai called the device "a significant advancement in safeguarding high-risk patients from sudden cardiac arrest."

Wearable defibrillator technology has seen steady improvement in recent years. The traditional LifeVest has been used for decades but is often cited by patients as uncomfortable and disruptive to daily life. Newer competitors have focused on miniaturization, usability, and real-time connectivity. For example, recent studies have explored wearable patches integrated with AI-driven detection algorithms and remote monitoring features, though few have yet received full FDA approval.

“Bringing the Jewel Patch-WCD to market represents a transformative moment for patients at risk of sudden cardiac arrest,” said Lee Smith, Jr., Element’s head of commercial operations. “This is the type of innovation that doesn’t just advance health care; it changes lives.”