FDA OKs Element Science’s Jewel Patch Wearable Cardioverter Defibrillator

Element Science has received U.S. Food and Drug Administration (FDA) approval for its Jewel patch wearable cardioverter defibrillator (Patch-WCD).

The Jewel Patch-WCD detects and treats life-threatening arrhythmias in patients with temporary, elevated risk for sudden cardiac arrest (SCA). The device continuously monitors the patient’s heart and treats specific life-threatening rhythms.

The Jewel Patch-WCD combines human-centered design with the latest machine learning advancements. It is water resistant to allow for continuous protection during showering, as well as a discreet profile.

A sophisticated algorithm and user-friendly design make it a tool patients can use in their homes and during daily activities to protect against sudden cardiac arrest.

“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 Element Science founder, president, and CEO Dr. Uday N. Kumar. “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.”

The Jewel Patch-WCD received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking in January 2024.

“Bringing the Jewel Patch-WCD to market represents a transformative moment for patients at risk of sudden cardiac arrest,” said Element Science head of commercial Lee Smith, Jr. “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.”