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【黑科技】“上帝视角”,AR手术指导系统获FDA批准

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发表于 2020-10-14 13:06:26 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><span>Augmedics是一家位于芝加哥的初创公司,主要业务是开发外科手术虚拟现实技术,近日Augmedics开发的一套AR系统——xvision获得FDA 510k批准。</span></p><p><br  /></p><p><span>Xvision脊柱系统是一种AR手术导航系统,该系统包括一个透明的近眼显示头戴式受话器,使用头戴式受话器将导航数据投影到外科医生的视网膜上。</span><span>头戴式耳机通过将3D导航数据投影到外科医生的视网膜上来模拟手术过程中的“ X射线视觉”。</span><span>,旨在使外科医生能够在手术过程中看到内部解剖结构,以期使手术更安全,更快捷。将投影传统的导航数据,以及实时和叠加的患者CT数据中手术工具的位置。</span></p><p><span><br  /></span></p><p><span>Augmedics在xvision上的第一个用例是脊柱外科,在此期间,外科医生可从改善的患者脊柱解剖结构可视化中受益。</span></p><p><br  /></p><p><p><img src="image/20201014/e76f1d3b198072ce452975feb29a81d5_2.png" /></p></p><p><br  /></p><p><span>来自芝加哥拉什大学医学中心进行的经皮实验室研究,为<span>xvision的准确性提供了评估证据,这也为<span>xvision</span>的获批提供了临床支持。</span></span></p><p><br  /></p><p><span>在这项研究中,外科医生在九个不同尸体的胸椎和sa腰椎脊柱区域放置了九十三枚螺钉。</span><span> 实际和虚拟螺丝位置的比较显示了98.9%的精度。</span><span> 这些结果证实了以前由约翰·霍普金斯医学(美国),谢巴泰勒·哈希默医学中心(以色列)和阿萨夫·哈罗费医学中心(以色列)的外科医生进行的尸体准确性测试。</span></p><p><span><br  /></span></p><p><span>2018年,以色列Sheba Tel Hashomer医疗中心和Asaf Harofeh医疗中心由Ran Harel博士和Yigal Mirovsky博士领导,为<span>xvision</span>启动了人体临床试验,招募多达22名接受脊柱螺钉植入的患者。</span><span> 这项研究将通过独立的放射线医师审查以及用户体验(通过问卷调查)再次评估螺钉的位置。</span><br  /></p><p><span></span></p><p><br  /></p><p><trans oldtip="According to Dr. Frank Philips, Professor of Orthopaedic Surgery at Rush, “The efficiency and accuracy this augmented reality technology enables in placing spinal implants without looking away from the surgical field – as well as the ability to ‘see the spine’ through the skin in minimally invasive procedures – differentiates the xvision from conventional spinal navigation platforms.” In terms of business model viability, Dr. Philips adds “The economics of the xvision system are also compelling in both the hospital and the surgicenter environment.”" newtip="拉什骨科外科教授弗兰克·菲利普斯(Frank Philips)表示,“这种增强现实技术能够在不远离外科领域的情况下植入脊柱,以及在微创手术中通过皮肤‘看到脊柱’的能力,将XVision与传统的脊柱导航平台区别开来。”在商业模式的可行性方面,飞利浦博士补充说,“XVision系统的经济学在医院和手术中心环境中都很有吸引力。”"><span>外科教授Frank Philips博士表示:“AR技术能够高效而准确地放置脊柱植入物,而不会离开手术区域-以及能够通过皮肤'看到脊椎'的能力在业务模型的可行性方面,Philips博士补充说:“ xvision系统的经济性在医院和手术中心环境中也很引人注目。”</span></trans></p><p><br  /></p><p><trans oldtip="Commenting on the clearance announcement, Augmedics founder and CEO Nissan Elimelech shared, “xvision is our first product of many to follow that will revolutionize surgery, as it gives surgeons the information they need, directly within their working field of sight, to instill technological confidence in the surgical workflow and help them do their jobs as effectively and safely as possible.”" newtip="奥格医疗公司的创始人兼首席执行官尼桑·埃利米勒(Nissan Elimelech)在评论这一清除声明时说:“XVision是许多人的第一款产品,它将为外科手术带来革命性的变革,因为它能让外科医生在他们的眼界内直接获得他们所需要的信息,在手术流程中灌输技术信心,并帮助他们尽可能有效和安全地完成工作。”"><span><span>Augmedics</span>的创始人兼首席执行官尼桑·埃利米勒(Nissan Elimelech)在评论公司产品时说:</span></trans><span>“这是向外科医生提供一种更直观的手术导航方法的关键一步,使他们能够始终将目光聚焦在患者身上。</span><span>”我们相信XVision有潜力提供精确的结果以及更便捷、更快速和更安全的手术”。</span></p><p><span></span></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#27939d"><p><a 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