What happened
Yukun (Beijing) Network Technology built AneurDoc, software that uses deep learning to detect visible aneurysms on head and neck CT angiograms. It helps trained doctors triage scans for intracranial aneurysms of 3 mm or more. 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 prospective multicenter study of 486 cases with an expert panel's reading as the reference. The report names the General Hospital of the PLA Northern Theater Command and Huangshi Central Hospital as trial sites. Case-level sensitivity was 95.42% (95% CI 91.95% to 97.69%) and specificity 96.34% (93.17% to 98.31%). Both lower bounds exceeded the target of 90%. The software took 4.55 minutes on average to reach a result, against 10.00 minutes for the expert panel. On 7 November 2023, 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 report does not say that the software's results guided any patient's care.
Sources
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Regulatory document, by authors with no tie to the system.
FAS 集的试验产品检出疑似头颈血管动脉瘤病例水平灵敏度为 95.42% (95%CI: 91.95%,97.69%)
经综合评价,在当前认知水平上,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。
Details
AI system
- Reported configuration
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Release 2.0 (full version 2.0.1.001)
- Workflow
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The software reconstructed head and neck CT angiography images and used deep learning to detect visible aneurysms. It produced automated text and table reports for doctors to assess. An expert panel's reading served as the reference standard.
Follow-up
- Conditions for replication
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The images are head and neck CT angiograms. The software triages for intracranial aneurysms of 3 mm or more. Trained doctors use the results and do not base a clinical decision on the software alone.
Entry details
- Sector
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Healthcare.
- Purpose
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Yukun (Beijing) Network Technology built AneurDoc to help trained doctors triage head and neck CT angiograms for intracranial aneurysms of 3 mm or more.
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model, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.
Cite this record
Peter H. Vartanian. (2026). AneurDoc flagged aneurysms on CT angiograms in China's review (AIBD-1088). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1088.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)