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.
Element Science says the device addresses limitations with traditional, garment-based WCDs. Those devices can treat sudden cardiac arrest (SCA), patient comfort and compliance can cause issues, the company says.
“Gaining the CE mark under the rigorous European Union Medical Device Regulation (EU MDR) as well as the UKCA mark are testaments to the strength of the development, testing, and clinical results of the Jewel P-WCD,” said Dr. Uday Kumar, founder, president and CEO.
Former Boston Scientific CEO Hank Kucheman serves as non-executive chair of the company’s board. He said:
“Element Science is on the leading edge of leveraging advancements in machine learning, wearable technologies, and miniaturization to revolutionize the way patients receive care.”
