DEEPVESSEL FFR judged better than CT angiography in China's review

What happened

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.