魚躍醫療(002223.SZ):無創呼吸機產品獲得美國食藥監局緊急使用授權
格隆匯4月1日丨魚躍醫療(002223.SZ)公佈,公司已於4月1日收到了美國食品藥品監督管理局(英文全稱“Food and Drug Administration”,“FDA”)的郵件通知,公司全資子公司蘇州魚躍醫療科技有限公司的無創呼吸機產品已獲得FDA簽發的緊急使用授權(英文全稱“Emergency Use Authorization”,“EUA”)。
美國衞生及公共服務部部長於當地時間2020年3月24日宣佈,在COVID-19大流行期間,允許緊急使用醫療設備(包括用作醫療設備的替代產品)的情況。依據美國相關法規,授權緊急使用呼吸機、經改裝用作呼吸機的麻醉機及經改裝用作呼吸機的正壓呼吸機(統稱為“呼吸機”)、呼吸機管接頭,以及FDA確定符合相關規定的安全、性能和標籤標準的呼吸機附件,用於在COVID-19大流行期間治療患者的醫療環境中的緊急使用。
公司上述產品此次獲籤的美國FDAEUA,是在疫情期間用於患者臨牀治療的臨時緊急授權,如果在緊急情況終止後,公司仍希望在美國市場銷售該產品,則需要完成已在進行中的相應FDA註冊工作。此前,公司無創呼吸機產品已取得了中國國家藥品監督管理局頒發的醫療器械註冊證並完成了歐盟CE認證,同時在國內一線抗擊疫情的工作中,其性能與品質也得到了良好的驗證。
由於新冠肺炎在海外的迅速蔓延,呼吸機產品作為患者治療所需的重要醫療設備之一,其需求量在全球市場呈爆發式增長。目前公司收到了大量的呼吸機海外訂單,由於呼吸機產品技術較為複雜、品控要求嚴格,上游供應商產能爬升需要一定時間,預計呼吸機訂單排隊情況還將持續,同時疫情的持續時間與影響也具有不確定性。
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