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微泰醫療-B(02235.HK)持續葡萄糖監測系統設備獲批上市
格隆匯 11-05 08:11

格隆匯11月5日丨微泰醫療-B(02235.HK)發佈公吿,國家藥監局已於2021年11月4日正式批准公司生產的創新產品“持續葡萄糖監測系統”(AiDEX G7)的註冊申請。公司的AiDEX G7持續葡萄糖監測系統是由一次性葡萄糖探頭、葡萄糖信號發射器、葡萄糖信號接收器、血糖管理應用軟件及配套附件組成。可用於糖尿病成年患者(≥18歲)的組織間液葡萄糖水平的連續或定期監測,該產品可提供並存儲實時葡萄糖值,供用户跟蹤葡萄糖濃度變化的趨勢。

根據披露,與市場上其他主要持續葡萄糖監測系統相比,該產品的核心技術採用了抗干擾電極設計和阻抗校正算法的電流╱阻抗雙模監測技術、高分子葡萄糖滲透膜材料合成技術、單工序傳感器電極加工和葡萄糖氧化酶固化工藝,屬國內首創,其臨牀優勢為可實現最長14天的使用期限內無需指尖血校準。該產品已於2020年5月獲國家藥監局認證通過可適用國家藥監局頒佈的《創新醫療器械特別審查程序》。該產品的多中心臨牀研究結果此前已經發表,與靜脈血蔘考值相比其平均相對誤差值(MARD)為9.08%,處於國際領先水平。

該產品被國家藥監局的上市批准,是繼公司的Equil貼敷式胰島素泵系統獲得國家藥監局上市批准後,創新研發產品組合的又一重要突破。這代表着我們在糖尿病監測及治療產品組合中的重大進展。取得國家藥監局的上市批准後,公司擬在中國商業化該產品,期待充分展示其臨牀優勢,造福億萬中國患者。

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