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Element Science Secures Regulatory Approval for Jewel® Patch-Wearable Cardioverter Defibrillator with CE Mark & UKCA Mark

Friday, January 26, 2024

Element Science, a pioneering company in health technology, has announced a significant milestone: the Jewel® Patch-Wearable Cardioverter Defibrillator (P-WCD) has received both the CE mark certification from the European Union and the UK Conformity Assessed (UKCA) marking from the BSI Group. This novel device aims to address the limitations of traditional garment-based WCDs, particularly regarding patient comfort and compliance.

Sudden cardiac arrest (SCA) remains a critical issue globally, with low survival rates. The Jewel P-WCD was specifically designed to improve patient compliance by integrating advanced machine learning algorithms and prioritizing user experience design, characteristics often seen in consumer wearables but less common in medical devices. Its regulatory approval under the stringent European Union Medical Device Regulation (EU MDR) and the UKCA mark reflects the device's robust development, testing, and clinical efficacy.

The Jewel P-WCD is a waterproof wearable defibrillator capable of detecting and treating life-threatening arrhythmias in patients at temporarily elevated risk for SCA. By continuously monitoring the patient's heart, it can intervene in specific life-threatening rhythms, potentially saving lives and enhancing patient care.

Source: businesswire.com

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