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GRAND RAPIDS, Mich., Oct. 23, 2023 /PRNewswire/ -- cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage medical device companies with innovative technologies, announced today that one of their portfolio companies, St. Louis, Missouri-based SentiAR, Inc., a pioneer in using Augmented Reality (AR) visualization technology for cardiac ablation procedures, has received their second FDA 510K clearance for CommandEP™, adding a new integration..
密歇根州大急流城,2023年10月23日/PRNewswire/-培养(MD)资本基金LP,专注于投资具有创新技术的早期医疗器械公司的资金,今天宣布其投资组合公司之一,位于密苏里州圣路易斯的SentiAR,Inc.,一家使用增强现实(AR)可视化技术进行心脏消融手术的先驱,已获得美国食品及药物管理局第二次批准510K命令™, 添加新的集成。。
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CommandEP™ integrates existing 3D cardiac mapping systems to create a real time 3D holographic interface that provides physicians with an interactive, 360-degree view of the patient's specific anatomy to allow them to deliver cardiac ablation therapy with more precision. The CommandEP system utilizes a specially designed headset worn by the physician allowing hands-free manipulation of the patient's data for the first time, in addition to real-time heart anatomy and catheter locations inside the heart.
命令™ 集成现有的3D心脏测绘系统,创建实时3D全息界面,为医生提供患者特定解剖结构的交互式360度视图,使他们能够更精确地提供心脏消融治疗。CommandEP系统采用医生佩戴的专门设计的耳机,除了实时心脏解剖和心脏内导管位置外,还可首次免提操作患者数据。
This technology provides physicians control of their digital tools during cardiac ablation procedures..
该技术为医生在心脏消融手术过程中提供对其数字工具的控制。。
cultivate(MD) is focused on partnering with medical device companies to deliver truly innovative solutions to market.
Culture(MD)专注于与医疗器械公司合作,为市场提供真正创新的解决方案。
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Berk Tas, CEO of SentiAR said, 'We are excited to have gained our second 510K clearance for our innovative CommandEP™ technology with a new integration. This new clearance allows us to continue expanding our clinical and industry partnerships. Our physicians have been looking for a tool that can provide full 3D visualization in real-time while allowing hands-free control of images.
SentiAR首席执行官Berk Tas说:“我们很高兴为我们的创新命令获得第二个510K的许可™技术与新的整合。这一新的许可使我们能够继续扩大我们的临床和行业合作伙伴关系。我们的医生一直在寻找一种工具,可以实时提供完整的3D可视化,同时允许免提控制图像。
We are honored to be able to provide this to our physicians.' .
我们很荣幸能够将其提供给我们的医生 .
Gregory Michaud, MD, Clinical Director, Telemachus & Irene Demoulas Family Foundation Center for Cardiac Arrhythmias at Massachusetts General Hospital said 'Our initial clinical experience with the CommandEP system has been promising. Being able to see patient anatomy in full 3D visualization with contact force allows us to identify targets and navigate more efficiently.
马萨诸塞州总医院Telemachus&Irene Demoulas家庭基金会心律失常中心临床主任Gregory Michaud博士说:“我们在CommandEP系统方面的初步临床经验非常有希望。通过接触力能够在完整的3D可视化中看到患者的解剖结构,使我们能够识别目标并更有效地导航。
We look forward to continuing our use of the system as new features are developed.'R. Sean Churchill, MD, MBA, Managing Director, cultivate(MD) Capital Funds and SentiAR Board Member said, 'cultivate(MD) is focused on partnering with early stage medical device companies to deliver truly innovative solutions to market.
随着新功能的开发,我们期待继续使用该系统。”R、 培养(MD)资本基金和哨兵董事会成员总经理Sean Churchill博士说,“培养(MD)专注于与早期医疗器械公司合作,为市场提供真正的创新解决方案。
This is why cultivate(MD) Capital Funds took the opportunity to lead SentiAR's series A round and become the company's largest stakeholder. We are excited for SentiAR's latest 510K clearance that allows the physician unmatched visibility and precision with their cardiac ablation procedures.'CommandEP is the first application of its kind in the world and SentiAR anticipates completion of new clinical studies later this year.About SentiAR:SentiAR, Inc., based in St.
这就是为什么培养(MD)资本基金借此机会领导SentiAR的一轮系列并成为公司的最大利益相关者。我们对SentiAR最新的510K清除感到兴奋,这使得医生的心脏消融程序具有无与伦比的可见性和精确度CommandEP是世界上第一个应用程序,SentiAR预计今年晚些时候将完成新的临床研究。关于哨兵:哨兵公司,总部位于圣。
Louis, MO, was founded by Dr. Jennifer Silva, MD, FHRS, FACC, FAHA, Dr. Jonathan Silva, PhD of Washington University in St Louis and Mike Southworth, MS. SentiAR received an SBIR award from NIH alongside support from BioGenerator and Cultivation Capital to start its journey alongside support from cultivate(MD), TechWald Holdings, Medventure Partners, Cultivation Capital Biogenerator and Harmonix.
密苏里州路易斯市由圣路易斯华盛顿大学医学博士Jennifer Silva博士,FHRS,FACC,FAHA,圣路易斯华盛顿大学Jonathan Silva博士和Mike Southworth博士创立,SentiAR女士获得NIH颁发的SBIR奖以及BioGenerator的支持和栽培资本,与栽培(MD),TechWald Holdings,Medventure Partners,栽培资本BioGenerator和Harmonix的支持一起开始旅程。
Following the founding team's vision SentiAR has created the first application of Mixed Reality technology for use during interventional procedures, starting with cardiac ablation procedures, including the treatment of atrial fibrillatio.
继创始团队的愿景之后,SentiAR创建了混合现实技术的首次应用,用于介入手术,从心脏消融手术开始,包括治疗心房纤颤。