10款醫療器械進入創新通道

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;" data-pm-slice="0 0 []">8月5日，國家藥品監督管理局醫療器械技術審評中心發布《創新醫療器械特別審查申請審查結果公示（2025年第7號）》。

依據國家藥品監督管理局《創新醫療器械特別審查程序》（國家藥監局2018年第83號公告），創新醫療器械審查辦公室組織有關專家對創新醫療器械特別審查申請進行審查，擬同意以下申請項目進入特別審查程序，予以公示。

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;" data-pm-slice="0 0 []">1.產(chan) 品名稱：產(chan) 前胎兒(er) 畸形超聲影像輔助診斷軟件

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：廣州愛孕記信息科技有限公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">2.產(chan) 品名稱：股骨近端髓內(nei) 釘係統

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：河北瑞鶴醫療器械有限公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">3.產(chan) 品名稱：經導管主動脈瓣係統

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：上海以心醫療器械有限公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">5.產(chan) 品名稱：陡脈衝(chong) 消融儀(yi)

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：杭州維納安可醫療科技有限責任公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">6.產(chan) 品名稱：鎳鈦合金動脈導管未閉封堵器

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：先健科技（深圳）有限公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">7.產(chan) 品名稱：腫瘤分子殘留病灶檢測試劑盒（聯合探針錨定聚合測序法）

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：蘇州吉因加生物醫學工程有限公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">8.產(chan) 品名稱：納秒脈衝(chong) 電場消融係統

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：上海商陽醫療科技有限公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">9.產(chan) 品名稱：房間隔造孔心房分流器

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">　申請人：晨興(xing) （南通）醫療器械有限公司

inkMacSystemFont, "Helvetica Neue", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; text-align: justify; text-indent: 0px; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;">10.產(chan) 品名稱：閉環胰島素輸注係統

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【來源：國家藥監局器審中心】

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