Jewel移动应用程序

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获批FDA!可穿戴式心脏转复除颤器
思宇MedTech· 2025-05-06 10:30
Core Viewpoint - The FDA approval of the Jewel Patch-WCD wearable defibrillator marks a significant advancement in providing a non-invasive solution for high-risk patients facing sudden cardiac arrest (SCA) [1][3]. Group 1: Product Features - Jewel Patch-WCD is designed with a low-profile, waterproof patch that allows for continuous ECG monitoring without disrupting daily activities, including sleep and showering [3][6]. - The device is intended for temporary high-risk patients, including those recovering from myocardial infarction or with severe cardiovascular diseases, with an estimated 500,000 patients in the US and Europe benefiting annually [6][9]. - The device has demonstrated high compliance, with an average daily wear time exceeding 23 hours during clinical trials, successfully identifying and treating arrhythmias without any reported deaths or serious complications [6][9]. Group 2: Technology and Innovation - Jewel Patch-WCD utilizes a machine learning-based arrhythmia recognition system, achieving a low inappropriate shock rate of 0.36 per 100 patients per month, significantly better than many similar devices [7][9]. - The device integrates with the Jewel mobile app for near real-time data transmission to healthcare providers, facilitating remote monitoring and personalized cardiovascular care [7][9]. Group 3: Company Background - Element Science, founded by Dr. Uday Kumar in 2011, focuses on developing next-generation wearable technologies for high-risk cardiac patients, particularly in preventing SCA [8]. - The company has raised $145 million in Series C funding, positioning itself as one of the fastest-growing startups in the wearable medical device sector [8].