DrBrain-AD flagged hippocampal changes on brain MRI in China's review

In the maker's trial that China's CMDE reviewed, DrBrain-AD flagged hippocampal abnormalities on brain MRI with a sensitivity of 0.9328 and a specificity of 0.9042.

  • Not rated an organization

    The accuracy was measured in the maker's pre-market trial, and the report does not say that the software's results guided any patient's care.

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

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Targets of 85% for sensitivity and 80% for specificity for the lower 95% confidence bounds. Measured.

Without the system
Targets of 85% and 80%
With it
Sensitivity 0.9328 (0.9020，0.9637) and specificity 0.9042 (0.8685，0.9399)
The system’s part
Not isolated. The trial measured the software's own readings and also scored doctors reading with it. It gave no figures for doctors reading alone, so the software's effect on their judgment is not isolated. The trial was the maker's own. The report says that the software analyzes the images with deep learning.
Not yet checked
LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Improved Task Accuracy
System
DrBrain-AD (磁共振图像辅助评估软件)
Made by
Shenzhen Yiwei Medical Technology Co., Ltd. (深圳市铱硙医疗科技有限公司)
Used by
Shenzhen Yiwei Medical Technology (registration trial with 514 patients at three hospitals)
Where
Xuanwu Hospital of Capital Medical University, the Second Xiangya Hospital of Central South University and the First Affiliated Hospital of Wenzhou Medical University, 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：磁共振图像辅助评估软件 (technical review report for the registration of magnetic resonance image assessment-aid software), acceptance no. CQZ2201033, applicant 深圳市铱硙医疗科技有限公司. 14 September 2023. Section 三、临床评价概述 (clinical evaluation).

    FAS 集软件独立阅片的灵敏度为 0.9328（0.9020，0.9637） ，特异度为 0.9042（0.8685，0.9399）
    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

Release 1.0 (full version 1.0.0.01)

Workflow

The software analyzed gray and white matter structures across the brain on T1-weighted MR images with deep learning. It gave an assessment of whether the hippocampus was abnormal for doctors to review.

Follow-up

Conditions for replication

Patients are aged 55 to 70. Radiologists review the images again. Clinicians also weigh the history, symptoms and other tests before they judge whether a patient has Alzheimer's disease.

Entry details

Sector

Healthcare.

Purpose

Shenzhen Yiwei Medical Technology built DrBrain-AD to help doctors assess abnormalities of the hippocampus on brain MR images of patients aged 55 to 70. Its results give imaging support for a diagnosis of Alzheimer's disease.

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Cite this record

Peter H. Vartanian. (2026). DrBrain-AD flagged hippocampal changes on brain MRI in China's review (AIBD-1090). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1090.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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