高視醫療(02407.HK):頻域生物測量儀獲得中國醫療器械註冊證
格隆匯8月4日丨高視醫療(02407.HK)宣佈,公司附屬公司高視創新科技有限公司("高視創新")的「頻域生物測量儀」近日已獲得由江蘇省藥品監督管理局批准的醫療器械註冊證。
2023年國家衞健委發佈的《中國眼健康白皮書》指出,中國青少年總體近視率約為53.6%。隨着近視羣體的不斷擴大,近視防控需求的市場也迅速增加。沙利文發佈的《中國眼鏡鏡片行業研究白皮書》指出,近年來我國近視防控市場規模不斷增長,2022年後開始加速,2023年市場規模已經達到人民幣146.8億元,同比增長43.2%。生物測量儀是近視防控的關鍵設備,能夠對眼軸長度、角膜曲率、晶體厚度等進行微米級的精確測量,從而能夠在監測青少年近視進展、評估近視防控手段的療效等方面起到重要作用,同時也是近視屈光手術術前精準評估必不可少的設備之一。
高視創新本次獲批的頻域生物測量儀(註冊證編號:蘇械注準20252161508),基於新一代頻域測量原理開發,相對於大部分傳統基於時域原理的同類生物測量儀產品,頻域測量原理具有更高的解析度、更快的成像速度以及更好的信噪比。設備還採用了創新的雙光路設計(專利號:CN118526152A),在進行眼部參數測量時能夠對患者角膜、視網膜、脈絡膜進行即時斷層成像,從而在近視隨訪的同時輔助醫生進行近視併發症的篩查。該設備由高視創新獨立自主研發,歷時兩年,目前已經實現了光、機、電相關關鍵零件的100%國產化。
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