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<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><section><section><section><section><section><p><br /></p><p><span>Vagus Nerve Stimulator获得FDA对哮喘患者的紧急许可,可以用来缓解患上新冠肺炎的哮喘病患者缓解症状。</span></p><p><span><br /></span></p><p><p><img src="image/20201014/b0ffd897c47efdb4134290412f356d77_2.jpg" /></p></p><p><br /></p><p><span>哮喘病本就是一种呼吸道疾病,会导致呼吸困难,而新冠肺炎则会加重症状,因此FDA为Vagus Nerve Stimulator颁布了紧急使用授权,以帮助患有新冠肺炎的的成年哮喘患者(或疑似感染患者)克服药物不合适或不足时的呼吸困难。</span></p><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><br /></section><p><br /></p><p><p><img src="image/20201014/4eef684a93e34bf6b13ae6d6e6f1d157_3.jpg" /></p></p><p><br /></p><p><span>gammaCore刺激器的工作原理是通过温和的电刺激来激活大脑和身体的重要连接通道vagus神经,由于vagus神经在调节痛觉方面起到重要作用,因此gammaCore能够缓解偏头痛等症状,而此前该产品也是用来缓解这类症状。与传统的迷走神经刺激疗法不同,<span>g</span><span>ammaCore</span>通过皮肤无创刺激神经,无需手术,避免了许多类似药物的副作用和与注射、吸入或基于药丸的药物相关的不便。</span></p><p><span><br /></span></p><p><p><img src="image/20201014/6e0419c99690316825298f607686c808_4.gif" /></p></p><p><span></span><br /></p><p><span><br /></span></p><p><span>而该产品之所以获得FDA的紧急授权是因为,最初gammaCore就是是作为哮喘病治疗</span><span>方式而展开研发。<span>获得FDA紧急授权也意味着认可了这款产品作为<span>哮喘急性治疗设备。</span></span></span></p><p><span><br /></span></p><p><p><img src="image/20201014/fef17a7f88e268a2e1e501e843e4adce_5.jpg" /></p></p><p><span></span><br /></p><p><span>新冠疫情发生后,包括个人防护装备、核酸检测、疫苗和其他有利于新冠患者的设备获得了FDA的紧急授权,全面投入到新冠患者的救助工作中。NMPA也有类似的应急审批通道,也有很多核酸检测和个人防护装备的厂家获得了NMPA的紧急授权,但是在一些提供个性化服务的器械领域,我国较美国尚有明显落后。</span><span>这一结果也可以看出,</span><span>我国医械企业更多的关注在提供民众的基本医疗需求上,而在更加人性化,更加细分的专业化领域与发达国家仍有差距。</span></p><p><br /></p></section></section></section></section></section></section></section></section></section></section></section></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 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