微识医疗获批NMPA首张实时动态影像AI产品三类证!创新医疗器械首个消化内镜AI产发表时间:2022-08-04 11:38 至此,微识医疗EndoScreener成为全球首个同时拥有的消化内镜医疗AI产品。与CT、MRI等静态医学影像不同,实时动态影像的智能辅助,AI正确或错误的提示都会对医生产生正面或负面的导向作用,从而改变了医学图像的获取,因此,。美国FDA早在2019年就公开宣布将前瞻性随机对照试验作为消化内镜辅助诊断产品的评审依据,临床证据的规格要求堪比PMA流程,所以截至目前仅有两款产品在美国获批。,,单一产品临床证据累积影响因子超过160,近三年被引用次数超过950次;这些严谨的临床证据先后肠镜检查是肠癌筛查的金标准,通过结肠镜发现并切除腺瘤等癌前病变是预防结直肠癌最有效的手段。“”微识医疗CEO刘敬家表示,“获益于创新医疗器械绿色通道的鼓励政策,EndoScreener在中国注册获批过程中节约了大量的时间和成本。作为企业公民,我们也必将用高性价比的产品和服务来回馈社会。结直肠癌是目前所有常见癌症中社会直接成本最高的癌种,相信通过广泛的参与国内国际双循环,公司的产品一定能够持续领先,实现临床效用的同时也创造卓越的卫生经济价值。”微识医疗(Wision A.I.)是一家人工智能医学影像软件公司,位于上海和成都。公司在泛函分析理论框架下,利用深度学习和并行计算的平台,将医学知识集成到灵活和可扩展的数学模型中,旨在使用少量开发样本实现AI临床价值,为医用光学影像领域提供改写临床指南级别的数字医疗创新。
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