{"id":"AIBD-0957","title":"China's CMDE finds that doctors using uAI-BreastTomoCare detected more breast masses on tomosynthesis in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, doctors using uAI-BreastTomoCare found 62.17% of breast mass lesions on tomosynthesis, against 50.42% without it.","date_observed":"2026-02-13","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"United Imaging Intelligence (Beijing) built uAI-BreastTomoCare, software that applies deep learning to digital breast tomosynthesis. It helps doctors detect breast masses in women aged 40 and over when they read the images with mammograms. 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, fully crossed multi-reader multi-case study of 432 subjects' images at three centers. Doctors read each case with and without the software. Lesion-level sensitivity for breast masses was 62.17% with the software and 50.42% without, a difference of 11.75% (95% CI 5.55% to 17.95%). Case-level specificity was 81.61% against 74.12%, which met the non-inferiority margin. Reading time was shorter with the software (P<0.001). On 13 February 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. The doctors read stored images, so the software guided no care. 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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：乳腺X射线断层图像辅助检测软件（CQZ2500562）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1775030830626008899.pdf","date":"2026-02-13","written_by":"independent","quote":"临床试验主要评价指标显示，乳腺肿块病灶检出的灵敏度（病灶层面）试验组为 62.17%，对照组为 50.42%，组间差值为11.75%，95%CI为(5.55%,17.95%)，区间下限大于优效界值 0，优效结论成立"},{"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：乳腺X射线断层图像辅助检测软件 (technical review report for the registration of breast X-ray tomosynthesis image detection-aid software), acceptance no. CQZ2500562, applicant 联影智能医疗科技（北京）有限公司. 13 February 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：乳腺X射线断层图像辅助检测软件（CQZ2500562）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1775030830626008899.pdf","date":"2026-02-13","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。"}],"replication":{"produced_by":["The software analyzed tomosynthesis images with deep learning and marked suspected breast masses.","Doctors read the tomosynthesis images together with the mammograms, with the software's marks as an aid."],"must_hold":["Patients are women aged 40 or over.","Trained doctors read the images and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*uAI-BreastTomoCare* helped doctors find more breast masses","metric":"62.17% of breast mass lesions on tomosynthesis, against 50.42% without it","comparator":{"against":"The same doctors reading the same tomosynthesis cases without the software","before":"50.42% lesion-level sensitivity","after":"62.17% lesion-level sensitivity","basis":"measured","quote":"临床试验主要评价指标显示，乳腺肿块病灶检出的灵敏度（病灶层面）试验组为 62.17%，对照组为 50.42%，组间差值为11.75%，95%CI为(5.55%,17.95%)，区间下限大于优效界值 0，优效结论成立","url":"https://www.cmde.org.cn/directory/web/cmde/images/1775030830626008899.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/1775030830626008899.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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