{"id":"AIBD-1064","title":"China's CMDE finds that doctors using uAI-CTA-HeadNeckVessels detected more brain aneurysms on CT angiograms in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, doctors using uAI-CTA-HeadNeckVessels detected 90.00% of intracranial aneurysms on CT angiograms, against 81.97% without it.","date_observed":"2024-09-20","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Shanghai United Imaging Intelligence built uAI-CTA-HeadNeckVessels, deep learning software that helps detect intracranial aneurysms of 3 mm or more on head and neck CT angiograms. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a retrospective, self-controlled, fully crossed multi-reader study of 484 cases at three institutions. Lesion-level sensitivity was 90.00% with the software and 81.97% without, a difference of 8.03% (95% CI 4.38% to 11.67%). Patient-level specificity was 92.46% against 87.88%. Reading time was 96.07 seconds with the software and 153.04 seconds without. Post-processing took 83.02 seconds against 905.44 seconds. On 20 September 2024, CMDE concluded that “该产品上市带来的受益大于风险” (putting the product on the market brings benefits that outweigh the risks). It recommended approval. NMPA later announced the approval and said that the product effectively improves diagnostic accuracy and efficiency. 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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：颅内动脉瘤CT造影图像辅助检测软件（CQZ2302223）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743990436956096747.pdf","date":"2024-09-20","written_by":"independent","quote":"试验组与对照组动脉瘤检出敏感度（以病灶为单位）分别为 90.00%和 81.97%，敏感度之差及 95%CI 为 8.03%（4.38%, 11.67%），其下限大于 0。"},{"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：颅内动脉瘤CT造影图像辅助检测软件 (technical review report for the registration of intracranial aneurysm detection-aid software for CT angiography images), acceptance no. CQZ2302223, applicant 上海联影智能医疗科技有限公司. 20 September 2024. Benefit-risk determination and overall opinion, CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：颅内动脉瘤CT造影图像辅助检测软件（CQZ2302223）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743990436956096747.pdf","date":"2024-09-20","written_by":"independent","quote":"经综合评价，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":"regulatory document","citation":"National Medical Products Administration (NMPA), China. CT Angiography Image-aided Detection Software for Intracranial Aneurysms Approved for Marketing. English-language notice, posted 19 February 2025. The notice names the maker as Shanghai United Imaging Healthcare Co., Ltd.","title":"CT Angiography Image-aided Detection Software for Intracranial Aneurysms Approved for Marketing","url":"https://english.nmpa.gov.cn/2025-02/19/c_1073672.htm","date":"2025-02-19","written_by":"independent","quote":"This product adopts deep learning-based head and neck vessel segmentation technology and multi-scale aneurysm detection technology, which effectively improves the diagnostic accuracy and efficiency of intracranial aneurysms, and is of great significance in improving the survival rate of patients."}],"replication":{"produced_by":["The software segmented the head and neck vessels and marked suspected aneurysms with deep learning.","Doctors read the CT angiograms with the software's marks as an aid."],"must_hold":["Images are head and neck CT angiograms, and aneurysms are 3 mm or larger.","Trained doctors read the images and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*uAI-CTA-HeadNeckVessels* helped doctors find more brain aneurysms","metric":"detected 90.00% of intracranial aneurysms on CT angiograms, against 81.97% without it","comparator":{"against":"The same doctors reading the same CT angiograms without the software, with imaging experts' readings as the reference","before":"81.97% lesion-level sensitivity","after":"90.00% lesion-level sensitivity","basis":"measured","quote":"试验组与对照组动脉瘤检出敏感度（以病灶为单位）分别为 90.00%和 81.97%，敏感度之差及 95%CI 为 8.03%（4.38%, 11.67%），其下限大于 0。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743990436956096747.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market trial on stored images 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/1743990436956096747.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: two independent regulatory documents. 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