HB-AI-T1 met its breast thermal triage targets in China's review

In the maker's trial of 743 women that China's CMDE reviewed, HB-AI-T1's triage of breast thermal images met its sensitivity and specificity targets against senior sonographers.

  • Not rated an organization

    The report says only that the triage reached its preset targets in the maker's pre-market trial, and it gives no figures and no outcome of 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

Preset targets for sensitivity and specificity, with a panel of senior sonographers' diagnoses as the reference standard. Measured.

The system’s part
Not isolated. The single-arm trial scored the software's triage against senior sonographers' diagnoses and set it against preset targets. It did not compare clinicians' triage with and without the software. The trial was the maker's own. The report says that the product uses a deep learning algorithm.
Not yet checked
LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Improved Task Accuracy
System
HB-AI-T1 (乳腺热层析影像辅助分诊软件)
Made by
Wuhan Haobo Technology Co., Ltd. (武汉昊博科技有限公司)
Used by
Wuhan Haobo Technology (registration trial with 743 women at three clinical institutions)
Where
Three clinical institutions in China that the report does not name
Stage
In a pilot
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：乳腺热层析影像辅助分诊软件 (technical review report for the registration of breast thermal tomography image triage-aid software), acceptance no. CQZ2400541, applicant 武汉昊博科技有限公司. 21 November 2025. Section 三、临床评价概述 (clinical evaluation).

    临床试验结论：软件辅助分诊相对于参考标准分析的灵敏度、特异度达到预期目标
    根据申请人提供的申报资料，经综合评价，在目前认知水平上，认为该产品的上市为适用人群带来的受益大于风险。

Details

AI system

Reported configuration

Release 1

Workflow

Users imported breast thermal tomography images from the maker's specified imaging system into the software by USB drive. The software segmented the breast region and used deep learning on several indicators to give a positive or negative triage prompt. A panel of senior sonographers' diagnoses served as the reference standard.

Follow-up

Conditions for replication

Patients are adult women who need a breast examination, without fever and not breastfeeding. Images come from the maker's specified thermal tomography system and probes. Clinicians read every image again, and the software does not replace ultrasound, mammography or MRI.

Entry details

Sector

Healthcare.

Purpose

Wuhan Haobo Technology built HB-AI-T1 to give trained clinicians a triage prompt on whether breast thermal tomography images of adult women show abnormal changes.

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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). HB-AI-T1 met its breast thermal triage targets in China's review (AIBD-1158). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1158.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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