第二代便携式MRI获批FDA！

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                    <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></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><section><span>来源：Hyperfine公司官网、器械汇等</span></section><section><br  /></section><section><span>2020年初，一经面世就备受业内关注的全球首台便携式MRI Hyperfine获得FDA批准上市，时隔仅半年，该产品的升级版Swoop便携式MRI再次获批FDA！</span></section><section><br  /></section><section><span>&nbsp;&nbsp;</span><p><img src="image/20201014/53d5f6a264a870d3de91b025f430961b_2.png" /></p></section><section><br  /></section><section><span>与前代产品Hyperfine相仿，Swoop便携式MRI机体底部装有万向轮，可直接推到患者床旁。</span></section><section><span><br  /></span></section><section><span><p><img src="image/20201014/b7c4027519b2db68e85a3267ef5a4b6c_3.png" /></p></span></section><section><span><br  /></span></section><section><span>使用墙上三叉式标准插座供电，工作人员通过无线连接到Swoop的平板电脑来操作设备。并通过无线平板电脑进行控制，使MR成像变得容易、即时和无缝。</span></section><section><br  /></section><section><p><img src="image/20201014/b63878884c423abb3c5c3402179c4bfb_4.png" /></p></section><section><br  /></section><section><span>根据前代产品Hyperfine的临床试验和反馈，Swoop在精密成像方面做出改进，且其适用范围扩大，包含0-2岁婴儿的成像<span>(体重需在2.6kg以上)</span>，</span><span>并在软件和易用性方面做出了很多改进，培训使用仅需30分钟。</span></section><section><span><br  /></span></section><section><span></span><span>该设备无需漫长等待，</span><span>在检查后</span><span>几分钟内即可得到</span><span>检查结果，</span><span>大大提升了</span><span>MRI诊断效率，适用于</span><span>神经重症监护室、急诊科、儿科、门诊和门诊手</span><span>术中心</span><span>等应用场景。</span></section><section><br  /></section><section><p><img src="image/20201014/2f5ead937c1c989b5aaeeacdc35ded3a_5.jpg" /></p></section><section><span>Hyperfine</span></section><section><br  /></section><section><span>在Hyperfine发布时，该公司就开始探索便携MRI产品在更多领域的应用，当时的方向在糖尿病足部疾病、脊柱疾病和肌肉骨骼创伤等方面，现在新一代的Swoop除了能够用于大脑成像，更成功开发出了关节和四肢成像功能。</span></section><section><br  /></section><section><span>此外，目前这款设备提供T1、T2、FLAIR和DWI + ADC 四个序列，全部基于3D和TSE / FSE。</span></section><section><br  /></section><section><p><img src="image/20201014/1f0df86f68ffdd876e632ac7a8035baa_6.png" /></p></section><section><br  /></section><section><span>据Hyperfine公司介绍，这种床旁磁共振的成本比目前大多数磁共振的年度服务合同还低，价格大约是传统磁共振的二十分之一，重量只有传统磁共振的十分之一，功耗减少35倍。</span></section><section><br  /></section><section><span>Hyperfine/Swoop高约55英寸(约1.4米)，宽约36英寸(折叠后)(约92厘米),重量为1400磅(约600kg)，使用永磁体，场强为0.064T。其所需要的最大功率是900W，但现有序列很少需要达到这个上限值，平均使用功率小于400W。</span></section><section><br  /></section><section><span>与Hyperfine设备一样，Hyperfine公司再次强调，Swoop是传统磁共振的补充，而非替代产品。但根据Hyperfine公司创始人兼CEO Jonathan Rothberg博士的设想，他希望打造一款适应多种环境，低功耗，低成本，可用于偏远落后，资源匮乏地区的MRI系统，而目前<span>Hyperfine</span><span>公司</span>的两代产品显然距离创始人的最初设想颇有距离。</span></section><section><span><br  /></span></section><section><span>目前，该公司正在为<span>Hyperfine</span>及<span>Swoop</span>申请其他国家的上市许可。</span></section><section><br  /></section><section><span>关于<span>Hyperfine</span></span></section><section><br  /></section><section><span>Hyperfine公司成立于2014年，是美国康涅狄格州4Catalyzer医疗科技孵化器的一部分。另一家公司生产掌上超声的公司——Butterfly Network也属于同一个孵化器。使用这款床旁磁共振时，用Butterfly超声探头对着患者都没有问题。</span></section><section><br  /></section><section><section data-color="#757576"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><section><br  /></section></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_7.gif" /></p></section><section 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