San Francisco, CA – May 1, 2025 – In a significant leap forward in the care of patients with cardiac disease, Element Science is proud to announce that its innovative Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD) has received U.S. Food and Drug Administration (FDA) approval of its Premarket Approval (PMA) application. This positive decision paves the way for the Jewel Patch-WCD to offer unparalleled protection for U.S. patients who have an elevated temporary risk of sudden cardiac arrest, revolutionizing the approach to lifesaving wearable therapeutics. The Jewel Patch-WCD received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking in January 2024.

Dr. Uday N. Kumar, Founder, President, and CEO of Element Science, reflected on the achievement, "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. 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."

Engineered with a deep understanding of patient needs, the Jewel Patch-WCD introduces a paradigm shift in wearable cardiac defibrillation. It combines the principles of human-centered design with the latest advancements in machine learning. With features like water resistance that allows for continuous protection during showering, and a discreet profile, the Jewel Patch-WCD allows patients to live their lives as they want, without the constraints of traditional devices. Its sophisticated algorithm and user-friendly design make it a reliable guardian patients can use in the comfort of their own homes and during their daily activities to protect against sudden cardiac arrest.
Dr. Christine Albert, the Stephen R. Corday, MD, Distinguished Chair in Cardiology in the Smidt Heart Institute at Cedars-Sinai, commented, “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.”

Lee Smith, Jr., the Head of Commercial at Element Science, highlighted the profound impact the Jewel Patch-WCD will have on patients, "Bringing the Jewel Patch-WCD to market represents a transformative moment for patients at risk of sudden cardiac arrest. The Jewel Patch-WCD represents a new freedom for these patients, enabling them to live with confidence while staying protected by life-saving technology. This is the type of innovation that doesn’t just advance healthcare; it changes lives, and we’re excited to bring that impact to patients and their families."

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