San Francisco– Element Science has received U.S. Food and Drug Administration (FDA) approval for its groundbreaking Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD), a next-generation device designed to protect individuals at temporary risk of sudden cardiac arrest. The approval marks a major milestone in wearable cardiac technology, combining life-saving capabilities with a discreet, patient-friendly design.
The Jewel Patch-WCD offers a novel alternative to traditional wearable defibrillators by integrating advanced machine learning algorithms with naturalistic design features. The device is water-resistant, allowing for continuous use during everyday activities, including showering, and features a low-profile patch that enables patients to go about their daily lives with minimal disruption.
“This is more than a regulatory milestone—it’s a reimagining of how life-saving technologies can fit into people’s lives,” said Dr. Uday N. Kumar, Founder, President, and CEO of Element Science. “The Jewel Patch-WCD is built around the belief that people using medical devices should feel like individuals, not patients. FDA approval brings that vision to life and transforms how we care for those at risk of sudden cardiac arrest.”
The FDA’s approval of the Jewel Patch-WCD follows its CE mark certification in the European Union and UK Conformity Assessed (UKCA) marking in Great Britain earlier this year. With the U.S. approval now secured, Element Science is poised to bring the device to patients nationwide who face temporary elevated cardiac risk, such as those recovering from a heart attack or newly diagnosed with heart failure.
Clinical experts say the Jewel addresses an urgent need in cardiac care. “The Jewel marks a significant advancement in safeguarding high-risk patients from sudden cardiac arrest,” said Dr. Christine Albert, Cardiology Chair at the Smidt Heart Institute at Cedars-Sinai. “Its cutting-edge design and technology fill a critical gap in patient management.”
The device’s launch is expected to reshape the standard of care for wearable defibrillation. “Bringing the Jewel Patch-WCD to market represents a transformative moment,” said Lee Smith Jr., Head of Commercial at Element Science. “It empowers patients to live with confidence and dignity, backed by life-saving innovation.”
With FDA approval now in hand, Element Science is moving forward with commercial plans to make the Jewel Patch-WCD available across the U.S., reinforcing its position at the forefront of wearable cardiovascular technology.
