106台新设备！2018年FDA批准认证的那些创新医疗器械

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                    <section><section powered-by="gulangu"><section><section><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>关注</section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><strong><span>来源：</span></strong></p><p><strong><span><br  /></span></strong></p><p>FDA于2019年1月28日表示，它2018年共批准了106台新设备，打破了17年预期批准99台新设备的纪录。自2015年4月该计划启动以来，该机构还批准了112项突破性设备指定请求，并在2018年期间批准或批准了9项突破性设备。快随随来看看过去一年中，FDA批准的那些创新医疗器械中的几个例子吧！</p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/3c4daf808199d0da4327488727f2818c_2.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><section><section></section><section><section></section><section></section><section></section></section></section><section><p><strong>可用于儿童的自动胰岛素给药系统</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><p><strong>Medtronic：MiniMedG系统</strong></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><span>美敦力的MiniMed&nbsp;?&nbsp;670G糖尿病管理系统包括一个传感器，可直接连接到人体以评估血糖水平，胰岛素泵和输液贴片可以输送胰岛素。该系统能自动监测血糖水平并相应地给予基础胰岛素，最初在美国批准用于14岁及以上的人群。</span></p><p><br  /></p><p><span>MiniMed&nbsp;?&nbsp;670G系统提供SmartGuard&nbsp;?，这是唯一一种通过提供两种新级别的自动胰岛素输送来模拟健康胰腺功能的技术。</span></p><p><span><br  /></span></p><p><iframe src="https://v.qq.com/iframe/player.html?width=500&height=375&auto=0&vid=m0833mar34d&auto=0" width="100%" height="580" frameborder="0"></iframe></p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><span>SmartGuard&nbsp;?功能：</span><br  /></p><p>自动模式：</p><p>根据您的CGM读数，每五分钟自动调整您的基础胰岛素。<span>有助于将您的血糖水平保持在目标范围内，从而减少低峰和高水平 - 白天和黑夜。</span></p><p>暂停前：</p><p>在达到预设的下限之前，停止胰岛素最多30分钟。</p><p>当你的等级恢复而没有麻烦的警报时自动重启胰岛素。<span>帮助您避免低点和反弹高点。</span></p></section></section></section></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><span>在一项105人的研究中，7至11岁的儿童使用该设备3.5个月。该研究评估了家庭使用和远程使用该系统，发现MiniMed 670G可安全用于患有I型糖尿病的幼儿。</span></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><section><section></section><section><section></section><section></section><section></section></section></section><section><p><strong>世界上最小的新生儿心脏瓣膜</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><p><strong>St. Jude Medical（现已被雅培收购）：</strong></p><p><strong>Master系列心脏瓣膜</strong></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p>Master系列机械心脏瓣膜是一种可旋转的双叶（双叶）瓣膜，设计用于植入主动脉或二尖瓣位置。双叶片设计由两个半圆形圆盘组成，这些圆盘在心跳期间响应血压变化而打开和关闭，类似于患者自己的瓣膜。</p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/98ec2a6ce286ac4abfdd19fb9d122a18_3.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p><p>Masters系列机械心脏瓣膜于1995年首次被批准用于患有主动脉或二尖瓣心脏瓣膜病变，受损或功能障碍的患者。该装置还被批准用于替换先前植入的主动脉或二尖瓣假体心脏瓣膜。</p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/9550a254f794eeaf0ff2383ddac58b9f_4.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>FDA批准了带有Hemodynamic Plus（HP）缝合袖口的Masters系列机械心脏瓣膜，包括15毫米的阀门尺寸，使其成为世界上最小的机械心脏瓣膜。FDA的批准扩大了可用的阀门尺寸范围，为年幼患者提供了另一种治疗选择。</p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><section><section></section><section><section></section><section></section><section></section></section></section><section><p><strong>&nbsp;世界上第一个用于评估轻度创伤性脑损伤</strong></p><p><strong>（脑震荡）的血液检测</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><p><strong>Banyan Biomarkers:脑创伤指标</strong></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p>“用于脑震荡评估的验血是美国公众和海外服务人员的重要工具，他们需要快速准确的检测，”FDA设备和放射健康中心主任医学博士Jeffrey Shuren说。“FDA的审查小组与测试开发人员和美国国防部密切合作，加快了对mTBI评估的血液测试，该测试既可以在美国大陆使用，也可以在美国军队服务的美国国外实验室使用。”</p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/6f3f711c0e286cd94fbbeb9aee656f07_5.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p><p>脑外伤指标通过测量从大脑释放到血液中并在头部受伤后12小时内测量的称为UCH-L1和GFAP的蛋白质水平起作用。mTBI /脑震荡后这些血液蛋白的水平可以帮助预测哪些患者可能通过CT扫描可见颅内病变，哪些不会。能够预测患者颅内病变的可能性是否较低，可以帮助医疗保健专业人员管理患者并决定进行CT扫描。测试结果可在3到4小时内获得。</p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><section><section></section><section><section></section><section></section><section></section></section></section><section><p><strong>使用人工智能检测糖尿病成人</strong></p><p><strong>糖尿病视网膜</strong><strong>病变的技术</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><p><strong>（IDx:IDxDR软件）</strong></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p>IDx的软件使用算法分析视网膜照相机拍摄的眼睛图像，是第一个被FDA批准的，利用人工智能检测患有糖尿病的成人糖尿病视网膜病变的医疗设备。</p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/d427f0c57951902d86c7bb5ccd5927ae_6.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p><p>医生使用IDx-DR软件将图像上传到云服务器，然后告诉医生它是否检测到轻度糖尿病视网膜病变。</p><p><br  /></p><p><iframe src="https://v.qq.com/iframe/player.html?width=500&height=375&auto=0&vid=y0833kij4tj&auto=0" width="100%" height="580" frameborder="0"></iframe></p><p><br  /></p><p>为了评估IDx-DR能够准确识别患有轻度糖尿病视网膜病变的患者的频率，FDA研究了来自900名糖尿病患者图像的临床研究数据。据该机构报道，该软件可以正确地检测到糖尿病视网膜病变的存在率为87.4％。</p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><section><section></section><section><section></section><section></section><section></section></section></section><section><p><strong>检测腕部骨折</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><p><strong>Imagen Technologies:OsteoDetect</strong></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p>这家总部位于纽约的公司的OsteoDetect软件旨在利用机器学习算法分析腕部X光片，以确定成人腕关节后 - 前和内侧 - 外侧X射线图像检查时桡骨远端骨折的区域。</p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/d7d68e5d3c9c88a6d269729fc6902174_7.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p><p>与无辅助性能相比，该软件的使用提高了读者检测腕部骨折的能力，提高了敏感性，特异性以及阳性和阴性预测值。</p><p><br  /></p><p>“人工智能算法具有巨大的潜力，可以帮助医疗保健提供者诊断和治疗疾病。这个软件可以帮助供应商在骨折的诊断更加快速检测的援助腕骨骨折，” FDA中心设备和体外诊断放射卫生厅和辐射健康代理副主任罗伯特·奥克斯说，在FDA发布。</p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><section><section></section><section><section></section><section></section><section></section></section></section><section><p><strong>美国第一个人造虹膜</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><p><strong>HumanOptics'CustomFlex</strong></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p>CustomFlex人工虹膜设计用于手术植入成人和儿童，以治疗虹膜完全缺失或损坏的个体，这些人患有先天性无虹膜疾病或眼睛受到其他损害。</p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/d89817aec03bfa8bcd9a8ea94a71f8cd_8.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><br  /></p><p>FDA表示，这种新认证的装置还可用于治疗由于其他原因或病症引起的虹膜缺陷，例如白化病，创伤性损伤或由黑色素瘤引起的手术切除。</p><p><br  /></p><p>CustomFlex虹膜由薄的可折叠医用级硅胶制成，可根据患者个性化定制和着色。该装置通过小切口植入，然后使用手术器械展开和平滑。</p><p><br  /></p></section></section></section></section><p><strong><span>本文由整理自外网，转载请注明出处。</span></strong></p><p>&nbsp;</p><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><p><span><strong>相关阅读</strong></span></p></section><p><p><img src="image/20201014/ec237188ae1e9c03eb4d9814f31b18ab_9.gif" /></p></p><p><br  /></p><p><span>『大开眼界』2018年度十大机器人技术！</span><br  /></p><p><br  /></p><p><span>『大开眼界』2018年“十大医疗器械”（下）</span><br  /></p><p><br  /></p><p><span>年终盘点|2018年医疗器械监管大事纪</span><br  /></p><p><br  /></p><p><span>改革FDA510 (k)，医疗器械上市将有新规！</span><br  /></p></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><span><strong><span><p><img src="image/20201014/225eae26a91575de7508aebe3e999278_10.jpg" /></p></span></strong></span></p>