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REVIEW

State-of-the-art review: Commercial artificial intelligence applications in cardiopulmonary imaging—from coronary fractional flow reserve to pulmonary embolism triage

Shun Dai1,2† Jingyu Zhong1,2† Zhengguang Xiao1,2*
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1 Department of Imaging, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
2 Shanghai Key Laboratory of Flexible Medical Robotics, Tongren Hospital, Institute of Medical Robotics, Shanghai Jiao Tong University, Shanghai, China
†These authors contributed equally to this work.
Received: 12 May 2026 | Revised: 18 June 2026 | Accepted: 22 July 2026 | Published online: 28 July 2026
© 2026 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
Abstract

Commercial artificial intelligence (AI) applications in cardiopulmonary imaging have expanded rapidly—723 Food and Drug Administration (FDA)-authorized radiology AI/machine learning (ML) devices had been identified by June 2024, representing 76% of 950 total cleared AI/ML medical devices, yet evidence supporting clinical adoption remains heterogeneous. This state-of-the-art review synthesizes published evidence across four cardiopulmonary subdomains (coronary, cardiac, aortic, and pulmonary artery imaging), applying the Fryback–Thornbury diagnostic efficacy hierarchy as a unified framework for cross-domain comparison, and integrating regulatory, ethical, and equity considerations aligned to the European Union (EU) AI Act (Regulation 2024/1689) and FDA lifecycle management milestones through early 2026. Evidence maturity varies markedly. Computed tomography-derived fractional flow reserve is supported by randomized trials and prospective registry data addressing clinical decision-making (Level 4); preliminary, non-replicated cost data are also available (Level 6), but no trial has demonstrated improvement in major adverse cardiac events (Level 5) as a primary endpoint. Cardiac AI achieves high reproducibility for automated quantification (intraclass correlation coefficient 0.80–0.95) but remains predominantly at Levels 1–2, with a single non-inferiority randomized trial. Aortic AI evidence is almost entirely retrospective (Level 2). Pulmonary embolism triage systems have demonstrated prospective workflow improvements, including reductions in time-to-diagnosis and radiologist miss rates, without demonstrated mortality benefit. Across all domains, only 5% of FDA-cleared devices underwent prospective testing, and only four of 213 (2%) European regulatory-approved radiology AI devices were clearly labeled for pediatric use. Algorithmic bias, explainability limitations, and immature post-market surveillance frameworks represent consistent cross-domain concerns. Realizing patient benefit requires prospective outcome-driven evaluation, representative training datasets, and rigorous post-market monitoring, particularly as EU AI Act high-risk obligations apply from August 2026.

Graphical abstract
Keywords
Artificial intelligence
Cardiopulmonary imaging
Fractional flow reserve
Cardiac quantification
Aortic dissection
Pulmonary embolism
Evidence hierarchy
Funding
None.
Conflict of interest
The authors declare no conflicts of interest.
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