Dr.Wise-AADS helped doctors find more brain aneurysms on CT

In the maker's trial that China's CMDE reviewed, doctors using Dr.Wise-AADS had lesion-level sensitivity for brain aneurysms on CT angiograms 10.85% higher than without it.

  • Not rated an organization

    Doctors read stored images in the maker's pre-market trial, and no patient's care depended on the software.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

Two independent regulatory documents support the benefit.

Compared with

The same doctors reading the same CT angiograms without the software, with imaging experts' readings as the reference. Measured.

The system’s part
In a randomized crossover, self-controlled design, doctors read the cases with and without the software, so the gains are attributed to the software. The trial was the maker's own. The report says that vessel segmentation and aneurysm detection use deep learning.
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Benefit type
Improved Task Accuracy
System
Dr.Wise-AADS (颅内动脉瘤CT造影图像辅助检测软件)
Made by
Hangzhou Deepwise (杭州深睿博联科技有限公司)
Used by
Hangzhou Deepwise (retrospective crossover reader trial on 965 cases at four institutions)
Where
Four trial institutions that the report does not name, for a registration in China
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
Last revised
1 November 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    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：颅内动脉瘤CT造影图像辅助检测软件 (technical review report for the registration of intracranial aneurysm detection-aid software for CT angiography images), acceptance no. CQZ2301114, applicant 杭州深睿博联科技有限公司. 26 February 2024. Section 三、临床评价概述 (clinical evaluation).

    FAS人群中试验组与对照组动脉瘤检出敏感度 （以病灶为单位）之差及 95%CI 为 10.85%（7.77%, 13.94%），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。

  2. Regulatory document, by authors with no tie to the system.

    National Medical Products Administration (NMPA), China. CT Image-aided Detection Software for Intracranial Aneurysms Approved for Marketing. English-language notice, 1 March 2024.

    This product adopts head and neck vessel centerline extraction and vessel segmentation technology, which greatly improves the sensitivity of intracranial aneurysm detection, and is of great significance in improving patients' quality of life and increasing their survival rate.

Details

AI system

Reported configuration

Release 1 (full version 1.1.0.1)

Workflow

The software segmented the head and neck vessels with deep learning and flagged suspected aneurysms. Doctors read the CT angiograms with the software's marks and vessel reconstructions as aids.

Follow-up

Conditions for replication

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

Healthcare.

Purpose

Hangzhou Deepwise built Dr.Wise-AADS to help trained doctors detect intracranial aneurysms of 3 mm or more on head and neck CT angiography images.

29 more questions not yet checked

model, provider, role, configuration, inputs and outputs, autonomy, human oversight, 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). Dr.Wise-AADS helped doctors find more brain aneurysms on CT (AIBD-1065). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1065.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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