Medtronic Announces FDA Clearance and Results of Artificial Intelligence Algorithms for Cardiac Monitoring

美敦力宣布心脏监测人工智能算法的FDA许可和结果

2021-07-28 23:30:44 Investing News Network

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AI Algorithms Enhance LINQ II™ Insertable Cardiac Monitor Diagnostic Accuracy for Improved Management of Patients Medtronic plc the global leader in medical technology, today announced U.S. Food and Drug Administration clearance for two AccuRhythm™ AI algorithms for use with the LINQ II™ insertable cardiac monitor . AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by LINQ II, … AI Algorithms Enhance LINQ II™ Insertable Cardiac Monitor Diagnostic Accuracy for Improved Management of Patients Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) clearance for two AccuRhythm™ AI algorithms for use with the LINQ II™ insertable cardiac monitor (ICM). 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 validation data will be presented this week at Heart Rhythm 2021, the Heart Rhythm Society’s annual Heart Rhythm meeting. 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 to be presented at Heart Rhythm 2021 include: “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. 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 . “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,” said Julie Brewer , president of the Cardiovascular Diagnostics and Services business at Medtronic. “We look forward to introducing additional diagnostic innovations to advance patient management in the future.” In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. About Medtronic Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 1 BiotronikBioMonitor™ 2 Technical Manual. 2017. 2 NölkerG, et al. J Cardiovasc Electrophysiol. 2016;27:1403-1410. 3 Confirm Rx™ ICM DM3500 FDA Clearance Letter. 2017. 4 PürerfellnerH, et al. Europace. 2018;20:f321-f328. 5 Catherine O`Shea, Melissa E. Middeldorp , Anthony G. Brooks , Jeroen M. Hendriks , Celine Gallagher , Niraj Varma , Rakesh Gopinathannair, Suzanne A. Feigofsky , Dennis H. Lau , Kevin R. Campbell , Prashanthan Sanders. Remote Monitoring Of Implantable Loop Recorders: False-positive Alert Episodes. Poster presented at: HRS 2020 Science Online. May 2020 . https://cslide-us.ctimeetingtech.com/hrs20/attendee/eposter/poster/71 . 6 AccuRhythm Clinician Manual Supplements M015316C001 and M015314C001. Contacts: Ryan Mathre Ryan Weispfenning Public Relations Investor Relations +1-651-335-2338 +1-763-505-4626 View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-fda-clearance-and-results-of-artificial-intelligence-algorithms-for-cardiac-monitoring-301342740.html SOURCE Medtronic plc View original content to download multimedia: http://www.newswire.ca/en/releases/archive/July2021/28/c1508.html News Provided by Canada Newswire via QuoteMedia
人工智能算法提高LINQ II™可插入式心脏监护仪诊断准确性改善患者管理全球医疗技术领导者美敦力公司今天宣布,美国食品药品监督管理局批准两种Accurhythm™人工智能算法用于LINQ II™可插入式心脏监护仪。AccuRhythm AI将人工智能应用于LINQ II收集的心律事件数据,… AI算法增强LINQ II™可插入式心脏监护仪的诊断准确性,以改善患者管理 全球医疗技术领导者美敦力(NYSE:MDT)今天宣布,美国食品药品监督管理局(FDA)批准了两种用于LINQ II™可插入式心脏监测器(ICM)的Accurhythm™AI算法。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,从而更好地诊断和治疗异常心律。AccuRhythm AI验证数据将于本周在心律学会的年度心律会议心律2021上公布。 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。 将在2021年心律展上展示的AccuRhythm AI验证结果包括: “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。 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。 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.” 美敦力与全球领先的临床医生、研究人员和科学家合作,为心血管疾病和心律失常的介入和外科治疗提供最广泛的创新医疗技术。该公司致力于提供最高质量的产品和服务,为世界各地的医疗保健消费者和供应商提供临床和经济价值。 美敦力公司(www.Medtronic.com)总部位于爱尔兰都柏林,是世界上最大的医疗技术、服务和解决方案公司之一,为全球数百万人减轻痛苦、恢复健康和延长寿命。美敦力在全球拥有90,000多名员工,为150多个国家的医生、医院和病人提供服务。该公司致力于与世界各地的利益相关者合作,共同推进医疗保健的进一步发展。 任何前瞻性陈述都受到风险和不确定性的影响,如美敦力提交给证券交易委员会的定期报告中描述的风险和不确定性。实际结果可能与预期结果有重大差异。 1 BiotronikBiomonitor™2技术手册。2017年。2 Nölkerg等人。心电生理。2016;27:1403-1410。3确认RX™ICM DM3500 FDA许可信。2017年。4 PürerFellnerh等人。Europace.2018;20:F321-F328。5 Catherine O'Shea、Melissa E.Middeldorp、Anthony G.Brooks、Jeroen M.Hendriks、Celine Gallagher、Niraj Varma、Rakesh Gopinathannair、Suzanne A.Feigofsky、Dennis H.Lau、Kevin R.Campbell、Prashanthan Sanders。植入式循环记录器的远程监测:假阳性警报事件。海报发布于:HRS 2020科学在线。2020年5月。https://cslide-us.ctimeetingtech.com/hrs20/attendee/eposter/poster/71。6 AccuRhythm临床医生手册补充M015316C001和M015314C001。 联系人: 莱恩·马特雷 莱恩·韦斯普芬宁 公共关系 投资者关系 +1-651-335-2338 +1-763-505-4626 查看原始内容下载多媒体:https://www.prnewswire.com/news-releases/medtronic-announces-fda-clearance-and-results-of-artificial-intelligence-algorithms-for-cardiac-monitoring-301342740.html 源|美敦力plc 查看原始内容下载多媒体:http://www.newswire.ca/en/releases/archive/july2021/28/c1508.html 加拿大新闻通讯社通过QuoteMedia提供的新闻

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