Element Science has announced the FDA premarket approval of its Jewel Patch wearable cardioverter defibrillator (WCD), marking a major step forward in wearable cardiac care. The device is designed for patients at elevated temporary risk of sudden cardiac arrest, providing life-saving protection while integrating seamlessly into everyday life.
Key Features:
- Human-Centered Design: The Jewel Patch-WCD boasts a discreet profile and water resistance, enabling continuous heart monitoring during normal activities.
- Machine Learning-Driven Algorithm: A sophisticated algorithm helps detect and treat life-threatening heart rhythms.
- Real-Time Patient Monitoring: A companion mobile app allows patients’ medical teams to receive therapy updates in near-real-time, ensuring timely intervention when necessary.
This approval follows CE mark approval in Europe in January 2024 and paves the way for expanded patient access in the U.S.
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