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鷹瞳科技-B(02251.HK)核心產品完成臨床試驗
阿思達克 09-14 12:18
鷹瞳科技-B(02251.HK)公布,已於近期完成核心產品Airdoc-AIFUNDUS (2.0)的臨床試驗,該產品為針對多適應症的人工智能輔助診斷醫療器械軟件。 Airdoc-AIFUNDUS (2.0)的適應症覆蓋範圍從上一版本的糖尿病視網膜病變拓展至高血壓視網膜病變、視網膜靜脈阻塞及年齡相關性黃斑變性(AMD),其覆蓋該等四種疾病的靈敏度和特異度表現結果優異,較中國國家藥品監督管理局已批准的AirdocAIFUNNDUS (1.0)的靈敏度(91.75%)和特異度(93.10%),均有進一步提升。公司指,正在準備為該等新適應症向國家藥監局提交更新第三類醫療器械註冊證書的申請。
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