IR-CT-PE flagged pulmonary embolism in a two-site trial in China

In the maker's two-site trial that China's CMDE reviewed, Infervision's IR-CT-PE flagged pulmonary embolism with 92.27% sensitivity and 96.91% specificity, above 80% targets.

  • Not rated an organization

    The report does not say that doctors acted on the prompts in the maker's pre-market trial, and it reports 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 of 80%, with an expert panel's case judgments as the reference. Measured.

Without the system
Targets of 80% for sensitivity and for specificity
With it
92.27% sensitivity and 96.91% specificity
The system’s part
Not isolated. The trial measured the software's triage calls against an expert panel and set them against targets of 80%. It did not compare doctors' diagnoses with and without the software. Its time comparison set the software's processing time against the hospitals' routine time to a report. The trial was the maker's own. The report says that the product uses deep learning.
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LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Improved Task Accuracy
System
IR-CT-PE (肺栓塞CT血管造影图像辅助分诊软件), models IR-CT-PE(A) and IR-CT-PE(B)
Made by
Infervision Medical Technology Co., Ltd. (推想医疗科技股份有限公司)
Used by
Infervision Medical Technology (trial with 485 cases at two institutions)
Where
Two trial institutions in China that the report does not name
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. CQZ2400926, applicant 推想医疗科技股份有限公司. 19 February 2025. Section 三、临床评价概述 (clinical evaluation).

    软件的分诊灵敏度 92.27%（95%CI，87.57%-95.61%），区间下限大于目标值 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 (full version 1.0.3.0)

Workflow

The software segmented the airways, pulmonary vessels, lung lobes and emboli with deep learning and gave a triage prompt for suspected acute pulmonary embolism. An expert panel's case judgments served as the reference.

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

Infervision Medical Technology built IR-CT-PE 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). IR-CT-PE flagged pulmonary embolism in a two-site trial in China (AIBD-1086). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1086.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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