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Home » Element Sciences earns FDA premarket approval for wearable defibrillator patch

Element Sciences earns FDA premarket approval for wearable defibrillator patch

May 1, 2025 By Sean Whooley

Element Science Jewel Wearable Cardioverter Defibrillator Patch-WCD (1)
The Jewel Patch-WCD. [Image courtesy of Element Science]
Element Science announced today that it received FDA pre-market approval for its Jewel Patch wearable cardioverter defibrillator (WCD).

San Francisco-based Element Science can now bring the Jewel Patch-WCD to U.S. patients with an elevated temporary risk of sudden cardiac arrest. This follows CE mark approval for the system in Europe in January 2024. The company says continued approvals help revolutionize the approach to live-saving wearable therapeutics.

Jewel Patch-WCD “introduces a paradigm shift in wearable cardiac defibrillation,” the company said in a news release. It combines a human-centered design with significant advancements in machine learning. Features include water resistance and a discreet profile. Element Science also developed a sophisticated algorithm to accompany a user-friendly design, it says.

The device continuously monitors a patient’s heart and treats specific life-threatening rhythms. Element Science designed it for continued protection during normal daily activities. It also has a companion mobile app 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,” said Dr. Uday N. Kumar, founder, president, and CEO of Element Science. 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.”

Jewel Patch-WCD joins the WCD offered by Kestra Medical Technologies on the U.S. market.

Filed Under: Artificial Intelligence (AI), Cardiovascular, Food & Drug Administration (FDA), Health Technology, Machine Learning (ML), Patient Monitoring, Pre-Market Approval (PMA), Regulatory/Compliance, Software / IT Tagged With: Element Science, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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