uAI-BreastTomoCare helped doctors find more breast masses

In the maker's trial that China's CMDE reviewed, doctors using uAI-BreastTomoCare found 62.17% of breast mass lesions on tomosynthesis, against 50.42% 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

An independent regulatory document supports the benefit.

Compared with

The same doctors reading the same tomosynthesis cases without the software. Measured.

Without the system
50.42% lesion-level sensitivity
With it
62.17% lesion-level sensitivity
The system’s part
In a fully crossed design, doctors read every case with and without the software, so the gain in sensitivity is attributed to the software. The trial was the maker's own. The report says that the product uses deep learning.
Not yet checked
LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Improved Task Accuracy
System
uAI-BreastTomoCare (乳腺X射线断层图像辅助检测软件)
Made by
United Imaging Intelligence (Beijing) Co., Ltd. (联影智能医疗科技（北京）有限公司)
Used by
United Imaging Intelligence (Beijing) (retrospective reader trial on images of 432 subjects from three centers)
Where
Three trial centers 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：乳腺X射线断层图像辅助检测软件 (technical review report for the registration of breast X-ray tomosynthesis image detection-aid software), acceptance no. CQZ2500562, applicant 联影智能医疗科技（北京）有限公司. 13 February 2026. Section 三、临床评价概述 (clinical evaluation).

    临床试验主要评价指标显示，乳腺肿块病灶检出的灵敏度（病灶层面）试验组为 62.17%，对照组为 50.42%，组间差值为11.75%，95%CI为(5.55%,17.95%)，区间下限大于优效界值 0，优效结论成立
    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。

Details

AI system

Reported configuration

Release 1.1 (full version 1.1-1-1-45)

Workflow

The software analyzed tomosynthesis images with deep learning and marked suspected breast masses. Doctors read the tomosynthesis images together with the mammograms, with the software's marks as an aid.

Follow-up

Conditions for replication

Patients are women aged 40 or over. Trained doctors read the images and do not base a clinical decision on the software alone.

Entry details

Sector

Healthcare.

Purpose

United Imaging Intelligence (Beijing) built uAI-BreastTomoCare to help trained doctors detect breast masses on tomosynthesis images of women aged 40 and over.

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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). uAI-BreastTomoCare helped doctors find more breast masses (AIBD-0957). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-0957.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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