Element Science Receives FDA Approval for the Revolutionary Jewel® Patch Wearable Cardioverter Defibrillator

Groundbreaking device sets new standard in the management of patients with an elevated risk of sudden cardiac arrest

Excerpt from the Press Release:

SAN FRANCISCO–(BUSINESS WIRE)–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.

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