《重大里程碑!美国 Additive Orthopedics 3D打印医用植入物产品获得针对全球骨科市场FDA许可》

  • 来源专题:中国科学院文献情报制造与材料知识资源中心 | 领域情报网
  • 编译者: 冯瑞华
  • 发布时间:2018-05-22
  • 3D打印技术在医疗领域的应用十分广泛,技术也一直在创新。但是这些技术还无法大规模投入市场以及临床使用,也往往无法获得美国食品及药物管理局(以下简称“FDA”)的许可。

    FDA在决定产品或设备是否可以安全使用时必须考虑许多因素。对于3D打印产品, FDA还会要求反馈及发布相关技术指导。并非所有企业及产品都能通过严格的考核并获得许可。

    Additive Orthopedics是专业的骨科制药及技术公司,3D打印足部及踝关节设备在市场占领先地位。

    早在2016年就获得了FDA两项许可,分别是首款3D打印钛数字融合植入物产品和3D打印槌状趾植入物及3D打印的截骨楔形系统。该公司获得FDA 510(k)许可的第四种3D打印设备“髓内微创Bunion矫正系统”于一年前商品化。

    近期Additive Orthopaedics 获得了针对全球骨科市场的“患者专用3D打印骨植入物”Patient Specific 3D FDA 510(k)许可。这对3D打印植入物在骨科领域的临床使用来说是一个巨大里程碑,意味着之后临床上可为患者解决种植体修复、肢体重建、骨骼创伤等问题。

  • 原文来源:http://www.xincailiao.com/news/news_detail.aspx?id=187602
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