Element Science Receives CE & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator

Element Science has received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking for its novel Patch Wearable Cardioverter Defibrillator (P-WCD), which was designed to address limitations with traditional garment-based WCDs.

In Europe, only 8-10% of the approximately 300,000 people who suffer from Out of Hospital Cardiac Arrests (OHCA) each year survive. The Jewel P WCD, which has been developed with a design focused on improving compliance, which has been clinically proven to lead to the delivery of life-saving therapy when needed, can significantly increase the chances of survival in OHCA, addressing a major public health issue in Europe.

Out-of-hospital SCA remains a significant problem in the US and Europe, with only about 10% of patients surviving. The Jewel was developed to address the compliance issues of garment-based WCDs by focusing on user experience design and by incorporating advanced machine learning algorithms, both of which are approaches common in consumer wearables but relatively uncommon in medical device development,” said Dr. Uday N. Kumar, Founder, President & CEO of Element Science.

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