Diagnostic performance of FDA-cleared and CE-marked AI systems for mammography screening: a systematic…

Meta-analysisEuropean journal of radiology· Aug 2026

Diagnostic performance of FDA-cleared and CE-marked AI systems for mammography screening: a systematic review and meta-analysis.

Putu Irma Wulandari, Ziba Gandomkar, Mary Rickard … Patrick Brennan

Breast ImagingMeta-analysisDiagnosisQ1IF 4.0

FDA/CE-cleared AI shows strong standalone accuracy detecting cancer on mammography

Diagnostic performance of FDA-cleared and CE-marked AI systems for mammography screening: a systematic review and meta-analysis.

Putu Irma Wulandari … Patrick Brennan

European journal of radiology · Aug 2026 · Q1 in Radiology

Purpose

To evaluate the diagnostic performance of FDA/CE-cleared AI systems for mammography screening and assess their roles across clinical workflows.

Methods

A systematic search was conducted in Scopus, Embase, and PubMed for full-text articles published from January 2018 to July 2024 evaluating commercially available FDA/CE-cleared AI for breast cancer detection using digital mammography (digital mammography) and/or digital breast tomosynthesis (digital breast tomosynthesis).

n = 42 studies

Results

AUC 1.0 is perfect; 0.89 shows strong accuracy telling cancer from normal scans

76.3%

Sensitivity

89.6%

Specificity

More results

Risk of bias was frequently high, particularly for flow and timing.

Prospective evaluations of AI-integrated workflows, including triage and second-reader replacement, showed non-inferior cancer detection with significant workload reduction compared with standard double reading.

More results

A single prospective study of AI as an additional reviewer reported additional cancer detection with minimal increase in recalls.

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Conclusion · 1 of 2

FDA/CE-cleared AI systems demonstrate promising diagnostic performance in breast screening.

Conclusion · 2 of 2

The strongest evidence supports workflow configurations that reduce radiologist workload, particularly triage and independent/supporting reader models, while prospective evidence supporting complete replacement of radiologists remains lacking.

Diagnostic performance of FDA-cleared and CE-marked AI systems for mammography screening: a systematic review and meta-analysis.

Diagnostic performance of FDA-cleared and CE-marked AI systems for mammography screening: a systematic review and meta-analysis.

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