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Element Science wins CE mark for patch-wearable cardioverter defibrillator

Element Science announced that it received CE mark approval for its novel patch-wearable cardioverter defibrillator (P-WCD).

The Jewell P-WCD also picked up the U.K. Conformity Assessed (UKCA) marking, clearing it for marketing in the U.K.

San Francisco-based Element Science developed Jewel with patient experience in mind, creating a low-profile, lightweight design. The water-resistant device allows patients to comfortably wear Jewel during daily activities like showering and exercising.

Element Science reported positive data from an FDA investigational device exemption trial for Jewel back in November 2023. Jewel remains investigational in the U.S.

The novel device continuously monitors a patient’s heart and treats specific life-threatening rhythms. Its accompanying Jewel Mobile App enables timely patient care by transmitting therapy information to the patient’s medical team in near real-time.

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