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<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>去年11月，曾报道过这款</span><span><strong>床旁磁共振系统Hyperfine</strong></span><span><strong>，</strong></span><span>当时我们还在猜测这款产品究竟何时能与我们见面，现在这款产品已经获得美国FDA批准！</span></p><p><p><img src="image/20201014/21808884fbed24cbbf270bacb0108567_2.gif" /></p></p><p><span>我们现在复习一下该产品，Hyperfine磁共振是由Hyperfine公司与耶鲁大学联合研发，是世界上第一台便携式、可以实现床旁实时扫查的MRI，值得注意的是，该产品为对高场强MRI的补充，而非替代，它的出现更主要是针对一些特殊的科室和医疗应用环境。</span></p><p><br /></p><p><p><img src="image/20201014/8a05e2ae3d6f7683007ef23382c286c9_3.png" /></p></p><p><br /></p><p><span>Hyperfine系统宽3英尺(约0.92米)，高5英尺(约1.53米)，使用GPU计算信息处理技术，采用<strong>永磁体</strong>，<strong>场强为0.064 T</strong>，磁场比目前标准的磁共振少20-40倍，可以在开放的环境下工作，不需要特殊屏蔽，通过无线平板电脑控制操作。</span></p><p><p><img src="image/20201014/21808884fbed24cbbf270bacb0108567_2.gif" /></p></p><p><iframe src="https://v.qq.com/iframe/player.html?width=500&height=375&auto=0&vid=p301673po9w&auto=0" width="100%" height="580" frameborder="0"></iframe></p><p><span></span><br /><span></span></p><p><span>据悉，Hyperfine的<strong>价格大约是传统磁共振的二十分之一</strong>，重量只有传统磁共振的十分之一，功耗减少35倍。</span></p><p><br /></p><p><span>FDA对Hyperfine的批准包括用于2岁以上患者的头部成像。Hyperfine公司表示，<strong>床旁磁共振的应用主要包括</strong>：</span></p><section data-role="list" data-color="#374aae"><ul><li><p><span>儿科患者；</span></p></li></ul></section><section data-role="list" data-color="#374aae"><ul><li><p><span>身体过于虚弱而无法移动的重症患者；</span></p></li></ul></section><section data-role="list" data-color="#374aae"><ul><li><p><span>头痛或头晕的急诊患者，可以快速诊断缺血性脑卒中、脑血肿和脑积水等问题；</span></p></li></ul></section><section data-role="list" data-color="#374aae"><ul><li><p><span>农村地区或偏远地区；</span></p></li></ul></section><section data-role="list" data-color="#374aae"><ul><li><p><span>院外诊断，比如紧急救护、海上军舰或游艇、运动医学应用。</span></p></li></ul></section><p><br /></p><p><span>在获得FDA批准之前，Hyperfine在耶鲁纽黑文大学(Yale New Haven University)、宾夕法尼亚医学院(Penn Medicine)、长岛好撒玛利亚人医院(Good Samaritan Hospital Long Island)、纽约长老会布鲁克林卫理公会医院( New York Presbyterian Brooklyn Methodist Hospital)和布朗大学(Brown University)进行了<strong>数千次扫描</strong>。<br /></span></p><p><br /></p><p><span>一项由Hyperfine公司和美国心脏协会合作科学奖(American Heart Association Collaborative Science Award)资助的初步研究发现，<strong>低场强床旁磁共振能够在患者床边获得安全、准确和实用的脑部图像</strong>。85名中风患者在症状出现后7天内接受了Hyperfine系统的检查，平均检查时间约为30分钟。</span></p><p><br /></p><p><span>大部分患者完成了整个检查，只有5名患者无法进入Hyperfine 30厘米的开口。6名患者出现幽闭恐惧症，不得不停止检查。<strong>全过程没有出现重大不良事件</strong>，而且由于Hyperfine是低磁场，<strong>无需将房间里的金属撤走</strong>。</span></p><p><br /></p><p><span><p><img src="image/20201014/6d6176573e278b1eec8f5385da3dce2b_5.jpg" /></p></span></p><p><br /></p><p><span>Hyperfine多次用于<strong>评估急性神经损</strong>伤，比如头部创伤和脑出血。</span></p><p><br /></p><p><span>目前，Hyperfine公司仍在与临床研究伙伴合作，<strong>寻求将设备应用于更多的适应证</strong>，同时希望在更多的国家获得监管许可。<strong>未来，Hyperfine将致力于</strong>：</span></p><section data-role="list" data-color="#374aae"><ul><li><p><span>提高图像质量；</span></p></li></ul></section><section data-role="list" data-color="#374aae"><ul><li><p><span>适用于更多的环境条件；</span></p></li></ul></section><section data-role="list" data-color="#374aae"><ul><li><p><span>使用机器学习来提取尽可能多的有意义的信息。</span></p></li></ul></section><p><br /></p><p><span>美国卒中协会(American Stroke Association)在2月19-21日于洛杉矶召开的国际会议上重点介绍了Hyperfine。</span></p><p><br /></p><p><span>部分来源：</span><span>器械汇</span><br /></p><p><br /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_6.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section 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发表于 2020-10-14 12:49:51