智通财经APP获悉，德适-B(02526)早盘涨超22%，高见428港元，再创上市新高。截至发稿，涨17.43%，报411港元，成交额2921.39万港元。
消息面上，德适宣布，公司自研的AI AutoVision®染色体核型辅助诊断软件正式获得国家药监局第三类医疗器械注册证。该证批准的适应症涵盖采用羊水样本进行出生缺陷产前诊断的染色体核型分析；及采用外周血样本进行辅助生殖相关染色体核型分析。
据董事会所知及公司目前可得资料，该注册证为全球首张针对染色体核型分析、具备异常识别能力且达L3级别的第三类医疗器械注册证；亦为首张基于大模型技术取得的医疗器械注册证。董事会认为，该证的取得体现了监管机构对iMedImage®医学影像大模型技术在医疗器械中安全性、有效性及临床应用价值的认可。
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