FDA Approves AI-Enabled Wearable Defibrillator. A life-changing innovation for both patients and families. (May 1, 2025)
FDA Approves AI-Enabled Wearable Defibrillator. A life-changing innovation for both patients and families. (May 1, 2025)
1. FDA Approval:
• The U.S. FDA has approved the Jewel Patch Wearable Cardioverter Defibrillator (Patch-WCD) by Element Science for patients at elevated risk of sudden cardiac arrest.
• The device had previously received CE and UKCA approval in Europe and the UK.
2. Key Features:
• Wearable patch with no daily maintenance, usable for up to 7 days continuously.
• The system includes a reusable defibrillator unit and two disposable skin patches containing electrodes and power sources. After 7 days, the patches are replaced, but the main defibrillator unit is reused.
• Built to be water-resistant and durable, allowing patients to continue normal daily activities like showering or light exercise.
• Incorporates AI algorithms to reduce false alarms and inappropriate shocks.
• Transmits real-time monitoring data to healthcare teams.
3. Clinical Impact:
• Designed to help patients feel like people, not patients.
• Aims to offer freedom and confidence to those living with the risk of sudden cardiac arrest.