FEops HEARTguide Authorized by FDA for Unprecedented LAAo Planning Capabilities

FEops HEARTguide获得FDA授权,具有前所未有的LAAo规划功能

2021-10-14 22:00:07 BioSpace


This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211014005139/en/ “The pre-operative insight provided by FEops HEARTguide™ is powerful and can help me to optimize decision making for selecting optimal device size and position," said Dr Jacqueline Saw, Vancouver General Hospital, Canada. “FEops HEARTguide™ is an intuitive platform I can use to discuss cases with the entire heart team to streamline my pre-op planning workflow.” “FDA authorization of FEops HEARTguide™ is a significant milestone as this is the first Interventional Cardiovascular Implant Simulation Software Device cleared on the US market,” said Peter Mortier, PhD, co-founder and CTO of FEops. “Research on this technology began more than 10 years ago. We have continued to develop it with the goal of helping healthcare professionals identify the most appropriate treatment strategy for each patient precisely, safely and efficiently. This De Novo clearance is only a first step, and we are already preparing for FDA 510(k) submissions for FEops HEARTguide™ LAAo workflow with Abbott’s Amplatzer™ Amulet™ device and Boston Scientific’s WATCHMAN FLX™ device.” *The Owner/Operator Number for this Registration is: 10082838 and the listing number: DEN200030. FEops HEARTguide™ is a one-in-its-kind procedure planning platform for structural heart interventions that provides physicians with unique insights to evaluate device sizing and positioning pre-operatively. The platform uses digital twin technology based on patient-specific virtual replicas of the heart. Besides the recent FDA clearance to enter the US market with its LAAo workflow with WATCHMAN™, FEops HEARTguide™ is also commercially available in the European Union, UK, Canada and Australia for its TAVI and LAAo workflows. About FEops HEARTguide™ FEops HEARTguideTM cloud-based procedure planning environment uses digital twin technology to provide clinicians and medical device manufacturers with first-ever insights into the interaction between transcatheter structural heart devices and specific patient anatomy – pre-operatively. Additionally, this includes also a range of quality controlled, validated and AI-enabled** anatomical analyses. Such insights have the power to help ultimately to improve clinical outcomes in real-world hospital settings, as well as to accelerate research and development of novel device-based solutions. ** Currently available only in the European Union, UK, Canada and Australia for its TAVI and LAAo workflows. About FEops Privately held FEops, headquartered in Gent, Belgium, is a digital health player offering cloud-based procedure planning solutions in the structural heart space combining digital twin and AI technologies. In September 2017, FEops announced that it closed a 6 million euros financing, led by Valiance, and joined by existing investors Capricorn Partners and PMV. In December 2019, FEops has been awarded a grant of Euro 3.2 million from the European Innovation Council (EIC) accelerator programme. www.feops.com View source version on businesswire.com: https://www.businesswire.com/news/home/20211014005139/en/ Press Matthieu De Beule, PhD CEO Tel: + 32 9 292 80 30 Email: matthieu.debeule@feops.com Source: FEops FEops HEARTguide authorized by FDA for unprecedented LAAo planning capabilities   View this news release online at: http://www.businesswire.com/news/home/20211014005139/en
本新闻稿以多媒体为特色。在这里查看完整版本:https://www.businesswire.com/news/home/20211014005139/en/ “FEops HeartGuide™提供的术前洞察力非常强大,可以帮助我优化选择最佳设备大小和位置的决策,”加拿大温哥华总医院的Jacqueline Saw博士说。“FEops HeartGuide™是一个直观的平台,我可以用来与整个心脏团队讨论病例,简化我的术前规划工作流程。” FEops联合创始人兼首席技术官彼得·莫蒂埃博士说:“FDA对FEops HeartGuide™的授权是一个重要的里程碑,因为这是美国市场上第一个获得批准的介入性心血管植入模拟软件设备。”“这项技术的研究始于10多年前。我们一直在开发它,目标是帮助医疗保健专业人员准确、安全和有效地为每个患者确定最合适的治疗策略。这项从头开始的许可只是第一步,我们已经在准备FDA 510(k)提交FEops心脏指南™LAAo工作流程与雅培的Amplatzer™护身符™设备和Boston Scientificial的WATCHMAN FLX™设备。“ *本次注册的所有者/运营商号码为:10082838,上市号码:DEN200030。 FEops HeartGuide™是一个独一无二的结构性心脏干预程序规划平台,为医生提供了独特的见解来评估手术前设备的大小和定位。该平台使用基于患者特定心脏虚拟复制品的数字孪生技术。除了最近FDA批准进入美国市场的LAAo工作流程与守望者™,FEops心脏指南™也在欧盟,英国,加拿大和澳洲的TAVI和LAAo工作流程的商业可用。 关于FEops心动指南™ FEops HEARTguideTM基于云的程序规划环境使用数字孪生技术,为临床医生和医疗设备制造商提供了对经导管结构性心脏设备和特定患者解剖结构之间相互作用的首次见解--术前。此外,这也包括一系列的质量控制,验证和AI-Enable**解剖学分析。这种洞察力最终有助于改善现实世界医院环境中的临床结果,并加速基于设备的新型解决方案的研究和开发。 **目前只在欧盟、英国、加拿大和澳大利亚提供TAVI和LAAo工作流。 关于FEops 私人控股的FEops总部位于比利时根特,是一家数字健康播放器,结合数字孪生和AI技术,在结构心脏领域提供基于云的过程规划解决方案。2017年9月,FEops宣布完成了一笔600万欧元的融资,由Valiance牵头,现有投资者摩羯座合伙人和PMV加入。2019年12月,FEops获得了欧洲创新理事会(EIC)加速器计划320万欧元的赠款。 www.feops.com 在businesswire.com查看源代码版本:https://www.businesswire.com/news/home/20211014005139/en/ 印刷机 Matthieu De Beule博士 首席执行官 电话:+32 9 292 80 30 电子邮件:matthieu.debeule@feops.com 资料来源:FEops FEops HEARTguide获得FDA授权,具有前所未有的LAAo规划功能 在网上查看此新闻稿: http://www.businesswire.com/news/home/20211014005139/en