The US Food and Drug Administration (FDA) has approved Element Science’s premarket approval application for its Jewel Patch Wearable Cardioverter Defibrillator (Patch-WCD) intended for cardiac care.
This approval enables the device to protect individuals in the country with a temporary elevated risk of sudden cardiac arrest.
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In January last year, the patch secured CE mark certification from the EU and UK Conformity Assessed marking.
Element noted that the patch is designed considering patient needs and offers a new approach to wearable cardiac defibrillation by integrating human-centred design with machine learning technology.
The device’s water resistance feature claims to offer continuous protection, even during sleeping, showering and when engaging in moderate exercise.
It enables individuals to maintain their lifestyle without the limitations imposed by traditional devices.
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By GlobalDataThe device’s algorithm and user-friendly interface ensure reliability for at-home individuals and protect them from sudden cardiac arrest during day-to-day work.
Additionally, the Jewel Mobile App facilitates prompt patient care by sending therapy data to the medical team almost instantaneously.
According to the company, the Jewel Patch WCD is primarily aimed at treating more than 500,000 US and European individuals who are at a heightened temporary risk of encountering a deadly cardiac arrhythmia.
Element Science CEO, president and founder Dr Uday Kumar said: “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 is 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.”
