uAI-PulmonaryEmbolism flagged pulmonary embolism in China's review

In the maker's retrospective trial that China's CMDE reviewed, uAI-PulmonaryEmbolism flagged pulmonary embolism with 95.09% sensitivity and 88.24% specificity, above 80% targets.

  • Not rated an organization

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

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, with an expert panel's reading as the reference. Measured.

Without the system
Targets of 80% for sensitivity and for specificity
With it
95.09% sensitivity and 88.24% specificity
The system’s part
Not isolated. The trial measured the software's triage calls against an expert panel's reading and set them against targets of 80%. It did not compare doctors' diagnoses or the timing of care with and without the software. The trial was the maker's own. The report says that the product uses deep learning.
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Benefit type
Improved Task Accuracy
System
uAI-PulmonaryEmbolism (肺栓塞CT血管造影图像辅助分诊软件)
Made by
Shanghai United Imaging Intelligence Co., Ltd. (上海联影智能医疗科技有限公司)
Used by
Shanghai United Imaging Intelligence (retrospective trial with 496 cases at three institutions)
Where
Three trial institutions in China that the report does not name
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：肺栓塞CT血管造影图像辅助分诊软件 (technical review report for the registration of pulmonary embolism CT angiography image triage-aid software), acceptance no. CQZ2400084, applicant 上海联影智能医疗科技有限公司. 13 September 2024. Section 三、临床评价概述 (clinical evaluation).

    软件分诊肺栓塞患者的灵敏度为 95.09%(95%CI: 91.42%, 97.24%)，灵敏度 95%置信区间下限高于目标值 80%
    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 1.0 (full version 1.0-0-2-27)

Workflow

The software analyzed pulmonary CT angiography with deep learning and gave a triage prompt for suspected acute pulmonary embolism. An expert panel's reading served as the reference standard.

Follow-up

Conditions for replication

Patients are adults with suspected acute pulmonary embolism. Trained physicians use the prompt and do not base a clinical decision on it alone.

Entry details

Sector

Healthcare.

Purpose

Shanghai United Imaging Intelligence built uAI-PulmonaryEmbolism to flag adults with suspected acute pulmonary embolism on pulmonary CT angiography so that trained physicians can triage them.

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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). uAI-PulmonaryEmbolism flagged pulmonary embolism in China's review (AIBD-1085). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1085.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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