{"id":"AIBD-0956","title":"China's CMDE finds that investigators using AI Local AutoVision analyzed karyotypes 23.23 minutes faster in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, investigators using AI Local AutoVision took 11.19 minutes on average per karyotype, against 34.42 minutes by hand.","date_observed":"2026-05-14","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Hangzhou Diagens Biotechnology built AI Local AutoVision, software that cuts, counts, identifies and arranges chromosomes in G-banded images and flags suspected abnormalities. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The report says that three of the software's functions use deep learning. The trial was the maker's own and enrolled 1,734 subjects at three hospitals in China. Every case was karyotyped by an expert panel, by investigators using the software and by traditional manual analysis. Against the panel, sensitivity was 100% with the software and 99.74% by hand, and specificity was 100% and 99.93%. Analysis took 11.19 minutes on average with the software and 34.42 minutes by hand. On 14 May 2026, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. Diagens announced that the administration issued the registration certificate on 20 May 2026. The report does not say that the software's results guided any patient's care.","category":"aggregate result","unexpected":false,"purpose":"Hangzhou Diagens Biotechnology built AI Local AutoVision to cut, count, identify and arrange chromosomes in karyotype images and to flag suspected abnormalities for trained professionals.","system":"AI Local AutoVision (染色体核型图像辅助诊断软件)","model_version":"Release 2 (full version 2.0.0.0)","developer":"Hangzhou Diagens Biotechnology Co., Ltd. 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The report says that three of the software's functions use deep learning."},"evidence":[{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：染色体核型图像辅助诊断软件 (technical review report for the registration of chromosome karyotype image diagnosis-aid software), acceptance no. CQZ2501137, applicant 杭州德适生物科技股份有限公司. 14 May 2026. Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：染色体核型图像辅助诊断软件（CQZ2501137）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1783924708399056481.pdf","date":"2026-05-14","written_by":"independent","quote":"研究者联合应用试验器械组较传统人工组减少核型分析用时 23.23min（95%CI：-23.67min，-22.80min）"},{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：染色体核型图像辅助诊断软件 (technical review report for the registration of chromosome karyotype image diagnosis-aid software), acceptance no. CQZ2501137, applicant 杭州德适生物科技股份有限公司. 14 May 2026. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：染色体核型图像辅助诊断软件（CQZ2501137）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1783924708399056481.pdf","date":"2026-05-14","written_by":"independent","quote":"经综合评价，在目前认知水平上，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"},{"kind":"press release","citation":"Hangzhou Diagens Biotechnology Co., Ltd. (stock code 2526). Voluntary announcement: the Company's core product, AI AutoVision®, received Class III medical device registration certificate from National Medical Products Administration. HKEXnews, 22 May 2026.","title":"Voluntary announcement: The Company's Core Product, AI AutoVision®, Received Class III Medical Device Registration Certificate from National Medical Products Administration","url":"https://www1.hkexnews.hk/listedco/listconews/sehk/2026/0522/2026052200323.pdf","date":"2026-05-22","written_by":"makers","quote":"on May 20, 2026, AI AutoVision®, the Company’s Core Product, received the Class III Medical Device Registration Certificate from the National Medical Products Administration of China","supports_benefit":false}],"replication":{"produced_by":["The software read metaphase images of G-banded chromosomes from amniotic fluid and peripheral blood samples.","It cut, counted, identified and arranged the chromosomes and flagged suspected abnormalities for the investigators to check.","An expert panel's karyotype analysis served as the reference standard."],"must_hold":["Trained professionals still analyze every chromosome, including those that the software does not flag.","Professionals decide whether a case is abnormal and write the karyotype and the report themselves.","Patients with blood diseases fall outside the intended use."],"echoes":[]},"paired_incident":null,"headline":"*AI Local AutoVision* cut karyotype analysis time in China's review","metric":"11.19 minutes on average per karyotype, against 34.42 minutes by hand","comparator":{"against":"Traditional manual karyotype analysis of the same cases, with an expert panel's analysis as the reference","before":"34.42±11.48min on average by traditional manual analysis","after":"11.19±5.48min on average with the software","basis":"measured","quote":"研究者联合应用试验器械的核型分析时间平均为 11.19±5.48min；传统人工核型分析时间平均为 34.42±11.48min","url":"https://www.cmde.org.cn/directory/web/cmde/images/1783924708399056481.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market trial and guided no care, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration.","source":"https://www.cmde.org.cn/directory/web/cmde/images/1783924708399056481.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document and the makers' press release. 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