FDA clears Medtronic’s AI algorithms for cardiac monitoring


2021-07-29 01:30:32 Mass Device


Medtronic (NYSE:MDT) announced today that the FDA cleared two of its AccuRhythm AI algorithms for use with the Linq II ICM. Fridley, Minn.–based Medtronic’s AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by the Linq II insertable cardiac monitor (ICM) to improve the information provided to physicians for better diagnoses and treatments for abnormal heart rhythms, according to a news release. The company will present data on the AccuRhythm algorithms for the Linq II ICM at Heart Rhythm 2021 this week. Medtronic said the now-cleared, cloud-based AccuRhythm algorithms address the two most common ICM false alerts: Afib and asystole. The Afib algorithm reduced false alerts by 74.1% and preserved 99.3% of true Afib alerts, the company noted, while the “pause” algorithm for asystole reduced false pause alerts by 97.4% and preserved 100% of true pause alerts. “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,” CMO of Medtronic’s cardiovascular diagnostics and services business Dr. Rob Kowal said in the release. The company plans to release the AccuRhythm algorithms on the CareLink network later this year to be used by all implanted Linq II devices in the U.S. “We are excited to integrate AI capabilities to further elevate the accuracy of Linq II ICM – and provide clinicians with greater confidence in patient care decisions,” president of Medtronic’s cardiovascular diagnostics and services business Julie Brewer said. “We look forward to introducing additional diagnostic innovations to advance patient management in the future.”
美敦力(纽约证券交易所代码:MDT)今天宣布,美国食品和药物管理局批准了其两个AccuRhythm人工智能算法用于Linq II ICM。 根据一份新闻稿,总部位于明尼苏达州弗里德利的美敦力公司的AccuRhythm AI将人工智能应用于Linq II可插入式心脏监测器(ICM)收集的心律事件数据,以改善提供给医生的信息,从而更好地诊断和治疗异常心律。 该公司将于本周在2021年心律展上展示Linq II ICM的精确算法数据。 美敦力表示,现在已经清除的基于云的AccuRhythm算法解决了两个最常见的ICM错误警报:Afib和ASYSTOLE。该公司指出,Afib算法将虚假警报减少了74.1%,保留了99.3%的真实Afib警报,而asystole的“暂停”算法将虚假暂停警报减少了97.4%,保留了100%的真实暂停警报。 美敦力心血管诊断和服务业务CMO Rob Kowal博士在新闻稿中说:“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导致的临床低效,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。” 该公司计划今年晚些时候在CareLink网络上发布AccuRhythm算法,供美国所有植入的Linq II设备使用。 美敦力心血管诊断和服务业务总裁朱莉·布鲁尔(Julie Brewer)表示:“我们很高兴集成人工智能功能,以进一步提高Linq II ICM的准确性,并为临床医生提供对患者护理决策的更大信心。”“我们期待着在未来引入额外的诊断创新来推进患者管理.”