Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Element Science, Inc.The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) is a wearable device that continuously monitors a patient's heart rhythm to detect life-threatening arrhythmias like ventricular tachycardia or fibrillation. It uses an AI/ML-based algorithm to analyze ECG signals and can deliver therapeutic shocks to restore normal rhythm. The device is designed for patients at risk of sudden cardiac arrest who are not candidates or refuse implantable defibrillators. It improves safety by providing continuous monitoring and timely treatment while allowing daily activities.
Intended Use
The Jewel WCD is indicated for patients 18 years of age and older who are at risk for Sudden Cardiac Arrest and are not candidates for or refuse an implantable defibrillator.
Technology
The system consists of adhesive electrode patches connected by cable to a reusable defibrillator unit. It continuously monitors ECG signals, employs an AI/ML-based arrhythmia detection algorithm to identify shockable rhythms (ventricular fibrillation or tachycardia), and delivers biphasic truncated exponential defibrillation shocks synchronized to the cardiac cycle. Accompanying software components provide data reporting and device status updates.
Performance
The device was extensively tested non-clinically for electrical safety, EMC, software, shock delivery, mechanical durability, biocompatibility, and wireless coexistence. Clinical performance was validated in a pivotal trial with 322 patients showing low inappropriate shock rate (<2 per 100 patient-months), high patient wear time (>21 hours/day), and successful detection and treatment of arrhythmias. Animal studies confirmed safety and effectiveness for defibrillation. Human factors testing confirmed usability.
Ready to Sharpen Your Edge?
Subscribe to join 11k+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.