{"id":"AIBD-1082","title":"China's CMDE judges that DEEPVESSEL FFR can diagnose coronary ischemia better than CT angiography and spare patients unneeded invasive procedures","summary":"China's CMDE judged that DEEPVESSEL FFR can diagnose functional myocardial ischemia better than coronary CT angiography alone. The report gives no figures from the maker's trials.","date_observed":"2020-01-06","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Keya Medical built DEEPVESSEL FFR, software that computes fractional flow reserve (FFR) from coronary CT angiography with deep learning. It helps trained staff assess ischemia in stable coronary artery disease before invasive angiography. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the application for Class III registration by 北京昆仑医云科技有限公司 (Beijing Kunlun Medical Cloud Technology). The maker ran two trials of its own, a prospective, blinded, self-controlled trial at three institutions and a retrospective trial at six. Both used FFR measured during invasive angiography as the reference. The report says that the product had high diagnostic value in the prospective trial, with low rates of serious and device-related adverse events. It gives no figures for either trial. On 6 January 2020, CMDE judged that, compared with CT angiography, the software “可以提高功能性心肌缺血的诊断性能，减少不必要的冠脉血管造影检查（ICA）和冠脉介入手术（PCI）” (can improve the diagnosis of functional ischemia and reduce unnecessary invasive angiography and coronary intervention). CMDE concluded that “该产品临床使用受益大于风险” (the clinical benefits of the product outweigh its risks) and recommended approval. It asked for post-market study of results between 0.75 and 0.85 and of diffuse disease.","category":"aggregate result","unexpected":false,"purpose":"Keya Medical built DEEPVESSEL FFR to compute fractional flow reserve from coronary CT angiography and help trained staff assess functional myocardial ischemia in patients with stable coronary artery disease before invasive angiography.","system":"DEEPVESSEL FFR (冠脉血流储备分数计算软件)","model_version":"Release 1.0 (full version 1.0.1)","developer":"Keya Medical, with 北京昆仑医云科技有限公司 (Beijing Kunlun Medical Cloud Technology Co., Ltd.) as the applicant in China","deployer":"北京昆仑医云科技有限公司 (Beijing Kunlun Medical Cloud Technology Co., Ltd.), the applicant (prospective trial at three institutions and retrospective trial at six)","location":"Trial institutions in China that the report does not name, three in the prospective trial and six in the retrospective trial","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.3","4.A.1.b.1"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"CMDE judged that diagnosis improves over CT angiography, and the report gives no figures from the maker's trials."},{"group":"personal","depth":null,"reason":"CMDE judged that patients can be spared unnecessary invasive angiography and coronary intervention, and the report gives no count of procedures avoided."}],"ai_role":{"status":"unassessed","statement":"The trials measured the software's FFR against FFR measured during invasive angiography. The report gives no figures and shows no comparison of diagnosis or care with and without the software. Both trials were the maker's own. The report says that the software segments the vessels and computes FFR with 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：冠脉血流储备分数计算软件 (technical review report for the registration of coronary fractional flow reserve computation software), acceptance no. CQZ1900346, applicant 北京昆仑医云科技有限公司. 6 January 2020. Section 五、临床受益风险评估 (clinical benefit-risk assessment).","title":"医疗器械产品注册技术审评报告：冠脉血流储备分数计算软件（CQZ1900346）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1738726326302048199.pdf","date":"2020-01-06","written_by":"independent","quote":"可以提高功能性心肌缺血的诊断性能，减少不必要的冠脉血管造影检查（ICA）和冠脉介入手术（PCI）"},{"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：冠脉血流储备分数计算软件 (technical review report for the registration of coronary fractional flow reserve computation software), acceptance no. CQZ1900346, applicant 北京昆仑医云科技有限公司. 6 January 2020. Section 综合评价意见 (concluding evaluation), CMDE's own judgment of benefit and risk and its recommendation to approve.","title":"医疗器械产品注册技术审评报告：冠脉血流储备分数计算软件（CQZ1900346）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1738726326302048199.pdf","date":"2020-01-06","written_by":"independent","quote":"基于当前认知水平，认为该产品临床使用受益大于风险，注册申报资料符合现行技术审评要求，建议予以注册。"},{"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：冠脉血流储备分数计算软件 (technical review report for the registration of coronary fractional flow reserve computation software), acceptance no. CQZ1900346, applicant 北京昆仑医云科技有限公司. 6 January 2020. Section 三、临床评价摘要 (clinical evaluation summary), the conclusion of the prospective trial.","title":"医疗器械产品注册技术审评报告：冠脉血流储备分数计算软件（CQZ1900346）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1738726326302048199.pdf","date":"2020-01-06","written_by":"independent","quote":"该产品用于冠心病诊断时诊断价值较高，严重不良事件及与器械相关不良事件发生率低，具有可接受的安全性，可满足临床需求，适用于临床。"}],"replication":{"produced_by":["The software segmented and reconstructed the coronary vessels on CT angiography with deep learning and extracted their centerlines.","It then computed FFR with deep learning.","FFR measured during invasive coronary angiography served as the reference standard."],"must_hold":["Patients have stable coronary artery disease, with stenosis between 30% and 90% on CT angiography.","Patients with acute coronary syndrome or other acute chest pain are excluded.","Doctors weigh the result with the patient's history, symptoms and other findings."],"echoes":[]},"paired_incident":null,"headline":"*DEEPVESSEL FFR* judged better than CT angiography in China's review","metric":null,"comparator":{"against":"Coronary CT angiography alone, in CMDE's statement of the main clinical benefit, which gives no figures","before":null,"after":null,"basis":"assumed","quote":"与冠脉CTA检查相比，可以提高功能性心肌缺血的诊断性能，减少不必要的冠脉血管造影检查（ICA）和冠脉介入手术（PCI）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1738726326302048199.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"CMDE's judgment rests on the maker's pre-market trials, and the report gives no figures and no outcome of 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/1738726326302048199.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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