What happened
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. The doctors read stored images, so the software guided no care.
Sources
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Regulatory document, by authors with no tie to the system.
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。
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。
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Regulatory document, by authors with no tie to the system.
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.
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.
Details
AI system
- Reported configuration
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Release 2.2 (full version 2.2-0-0-72)
- Workflow
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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.
Follow-up
- Conditions for replication
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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.
Entry details
- Sector
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Healthcare.
- Purpose
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Shanghai United Imaging Intelligence built uAI-CTA-HeadNeckVessels to help trained doctors detect intracranial aneurysms of 3 mm or more on head and neck CT angiography images.
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Cite this record
Peter H. Vartanian. (2026). uAI-CTA-HeadNeckVessels helped doctors find more brain aneurysms (AIBD-1064). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1064.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)