Medtronic Awarded FDA Clearance for 2 AI Algorithms for Cardiac Monitoring


2021-07-31 05:00:07 HIT Consultant


What You Should Know: – Medtronic announced U.S. Food and Drug Administration (FDA) clearance for two AccuRhythm™ AI algorithms for use with the LINQ II™ insertable cardiac monitor (ICM) – and the presentation of AccuRhythm AI validation data this week at Heart Rhythm 2021. – AccuRhythm AI applies artificial intelligence (AI) to heart rhythm event data collected by LINQ II, improving the accuracy of information physicians receive so they can better diagnose and treat abnormal heart rhythms. AccuRhythm AI Benefits The small, wireless LINQ II ICM is the world’s most accurate ICM,1-4 and the new cloud-based AccuRhythm AI algorithms further enhance LINQ II ICM’s delivery of accurate heart rhythm alerts. The algorithms address the two most common ICM false alerts – atrial fibrillation (AF), an irregular or rapid rhythm in the upper chambers of the heart; and asystole, a long pause between heartbeats. 5-6 Medtronic developed the AccuRhythm AI platform and initial algorithms using its proprietary, diverse and debiased database of more than 1 million electrocardiogram heart rhythm episodes. AccuRhythm AI Validation Results  AccuRhythm AI validation results to be presented at Heart Rhythm 2021 include:– The AF algorithm reduced LINQ II ICM false AF alerts by 74.1% and preserved 99.3% of true AF alerts.– The Pause algorithm reduced LINQ II false pause alerts by 97.4% and preserved 100% of true pause alerts. Availability The AccuRhythm AI algorithms will be released on the CareLink™ Network later this year for use by all implanted LINQ II devices in the United States. “Applying AccuRhythm AI to LINQ II data is a significant ICM innovation, enabling us to reduce clinical inefficiencies resulting from false alerts, and help physicians better identify and focus on the actionable data they need to treat their patients,” said Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic.
你应该知道的是: -美敦力宣布美国食品药品监督管理局(FDA)批准两种用于LINQ II™可插入心脏监测仪(ICM)的AccuRhythm™AI算法,并于本周在2021年心律会议上展示了AccuRhythm AI验证数据。 -AccuRhythm AI将人工智能(AI)应用于LINQ II收集的心律事件数据,提高医生接收信息的准确性,以便更好地诊断和治疗异常心律。 AccuRhythm AI优势 小型无线LINQ II ICM是世界上最精确的ICM,1-4,新的基于云的AccuRhythm AI算法进一步增强了LINQ II ICM提供准确的心律警报的能力。该算法解决了两种最常见的ICM假警报--心房颤动(AF),在心脏上腔不规则或快速的节律;还有心搏停止,心跳之间长时间的停顿。5-6美敦力利用其专有的、多样化的、具有倾向性的100多万个心电图心律事件数据库开发了AccuRhythm AI平台和初始算法。 AccuRhythm AI验证结果 AccuRhythm AI验证结果将在2021年的Heart Rhydramme上公布:-AF算法将LINQ II ICM假AF警报减少了74.1%,保留了99.3%的真AF警报。-暂停算法将LINQ II假暂停警报减少了97.4%,保留了100%的真暂停警报。 可用性 AccuRhythm人工智能算法将于今年晚些时候在CareLink™网络上发布,供美国所有植入的LINQ II设备使用。 “将AccuRhythm AI应用于LINQ II数据是ICM的一项重大创新,使我们能够减少虚假警报造成的临床低效,并帮助医生更好地识别和专注于治疗患者所需的可操作数据,”Medtronic心血管产品组合的心血管诊断和服务业务的首席医疗官Rob Kowal医学博士说。