FDA Approves Element Science’s Wearable Defibrillator Patch

Element Science has received clearance from the U.S. Food and Drug Administration (FDA) for its Jewel Patch-Wearable Cardioverter Defibrillator (WCD), following earlier regulatory approvals in the U.K. and Europe in early 2024. The device offers a non-invasive option for patients at temporarily elevated risk of sudden cardiac arrest, including individuals recovering from a heart attack or with other significant cardiovascular disease.

The Jewel system is designed to be worn continuously, including during sleep and showers, due to its water-resistant and low-profile design. The system includes a reusable defibrillator unit, a battery pack, and two single-use electrode skin patches. These patches are designed to be replaced once a week.

According to Element Science, the Jewel Patch-WCD was developed to provide patients with a life-saving device that integrates into daily life. Element Science President and CEO Uday Kumar stated, “The Jewel Patch-WCD is the culmination of a vision to give patients a life-saving device that seamlessly integrates into their daily lives.” 

In 2024, the company presented clinical data from a pivotal U.S. trial involving approximately 300 participants. The study reported a median wear time of more than 23 hours per day. The device detected and delivered corrective shocks in eight episodes of ventricular tachycardia or fibrillation across six patients. All abnormal heart rhythms were converted with the first shock delivered by the device. No deaths or serious complications were reported during the period participants were enrolled in the study.

Element Science also reported its first real-world patient save during the study in August 2022. The patient, located in a rural area distant from first responders, experienced a life-threatening arrhythmia within a week of hospital discharge. The device detected the arrhythmia and responded accordingly.

The company also released data regarding the rate of inappropriate shocks delivered by the device. The Jewel system recorded 0.357 inappropriate shocks per 100 patient-months. These findings were published in the Journal of the American College of Cardiology.

Element Science is headquartered in San Francisco. In March 2020, it raised $145 million in a Series C venture capital round. The round was led by Deerfield Healthcare and Qiming Venture Partners USA. Additional investors included Cormorant Asset Management, Invus Opportunities, Third Rock Ventures, and Google Ventures.