Recently, Element Science announced that its wearable defibrillator patch has been approved by the U.S. Food and Drug Administration (FDA) after being approved by British and European regulators early last year. This non-invasive device provides an innovative solution for patients with a temporarily increased risk of cardiac arrest.

It is reported that the device is suitable for patients recovering from heart attacks and other patients with serious cardiovascular diseases. The Jewel Patch-WCD wearable cardioverter defibrillator system adopts a lightweight and waterproof design, which supports continuous wear during sleep and showering. The system includes a reusable defibrillator device, a battery pack, and a disposable electrode patch that is replaced once a week.

Uday Kumar, President and CEO of Element Science, said that the Jewel patch-type external defibrillator has realized the vision of seamlessly integrating life-saving equipment into patients' daily lives. This FDA approval not only means the achievement of a regulatory milestone, but also marks a major advancement in clinical treatment concepts-even if facing the risk of cardiac arrest, patients can regain a complete life through cutting-edge treatment technology.

Last year, Element announced the data of a key clinical trial conducted in the United States. The study included approximately 300 subjects, and the median daily wearing time of the device exceeded 23 hours. In 8 events of ventricular tachycardia or ventricular fibrillation in 6 patients, the device successfully detected and delivered corrective shocks, and all dangerous heart rhythms returned to normal after the first shock.

The company said no deaths or serious complications were observed during the trial. In August 2022, the device successfully rescued the patient for the first time in a real-world application: a patient in a rural area who developed a fatal arrhythmia one week after being discharged from the hospital was saved by timely electric shocks away from emergency personnel.

It is also worth mentioning that in 2020, Element completed a Series C financing round of US$145 million, jointly participated by Deerfield Healthcare, Qiming Venture Partners US, Google Ventures and others, and is regarded as one of the fastest growing startups in the field of wearable medical devices.

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