微創機器人-B(02252.HK):鴻鵠®骨科手術機器人獲歐洲CE認證
格隆匯12月5日丨微創機器人-B(02252.HK)宣佈,集團自主研發的Sky WalkerTM膝關節導航定位系統(中國註冊名稱鴻鵠®,"鴻鵠®")成功獲得歐洲CE認證,成為國內首款獲得歐洲CE認證的關節置換手術機器人。同時,鴻鵠®亦是截至目前第一且唯一一款同時獲得中國國家藥品監督管理局("NMPA")批准、美國食品藥品監督管理局("FDA")及CE認證的國產手術機器人。
鴻鵠®獲得CE認證,是集團踏出進軍歐盟市場的第一步,同時,這也是鴻鵠®繼今年4月獲得NMPA上市批准、7月獲得FDA認證之後創造的又一重大成就。鴻鵠®在一年之內連續在中國、美國、歐盟三地獲證,顯示了國產手術機器人強大的技術實力和產品優勢,標誌着集團初步完成了全球重點區域准入佈局,這也將助力集團全球化戰略的加速推進,普惠更多全球患者,實現"讓天下沒有難做的手術"的初心。
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