Research map: Predetermined Change Control Plan Adoption and Documentation Transparency in FDA-cleared Radiology Artificial Intelligence/Machine Learning Devices

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Papers in this map

  1. A scoping review of reporting gaps in FDA-approved AI medical devices · Vijaytha Muralidharan · 2024 · 191 citations · Cited by this paper
  2. The Agile Stage Model: A Minimally Viable Framework for Developing and Governing Digital Therapeutics, Including Agentic Artificial Intelligence Systems (Preprint) · Mark Seidman · 2026 · Cites this paper
  3. Impact of Exposure Parameters on Deep Learning Models in Chest Radiography and Implications for Deployment · 2026 · Related
  4. Understanding and Mitigating Bias in Imaging Artificial Intelligence · Ali Shah Tejani · 2024 · 136 citations · Cited by this paper
  5. In silico biomedicine in the era of artificial intelligence: opportunities and challenges · Faizan-e- Mustaffa · 2026 · Cites this paper
  6. Commercial AI Model Diagnostic Accuracy for Intracranial Large- and Medium-Vessel Occlusion at Emergency CT Angiography · 2026 · Related
  7. Exploring Equivalence Testing with the Updated TOSTER R Package · Aaron R. Caldwell · 2022 · 121 citations · Cited by this paper
  8. AI Triage of Normal Chest Radiographs: A Silent Trial and Failure Analysis · 2026 · Related
  9. Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use · Daniel Windecker · 2025 · 96 citations · Cited by this paper
  10. Open-Source Dataset for the RSNA Screening Mammography Cancer Detection Challenge · 2026 · Related
  11. Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices · Phoebe Clark · 2023 · 70 citations · Cited by this paper
  12. From Futile to Feasible: Improving Assessment of Stenosis in Heavily Calcified Coronary Arteries · 2026 · Related
  13. Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China · Daolu Tang · 2025 · 44 citations · Cited by this paper
  14. Development and Validation of a Deep Learning–enabled Single Breath-hold Abbreviated MRI Protocol for Hepatocellular Carcinoma Diagnosis · 2026 · Related
  15. Artificial intelligence for MRI stroke detection: a systematic review and meta-analysis · Jonas Asgaard Bojsen · 2024 · 41 citations · Cited by this paper
  16. Tumor-preserving Deformable Registration of Longitudinal DCE Breast MRI during Neoadjuvant Chemotherapy · 2026 · Related
  17. US FDA Approval of Pediatric Artificial Intelligence and Machine Learning–Enabled Medical Devices · Ryan Brewster · 2024 · 39 citations · Cited by this paper
  18. Clinic-aligned Dual Distillation of Video and Image Foundation Models for Automated Breast Cancer US Diagnosis · 2026 · Related
  19. Benefit-Risk Reporting for FDA-Cleared Artificial Intelligence−Enabled Medical Devices · John C. H. Lin · 2025 · 35 citations · Cited by this paper
  20. Editor’s Recognition Awards · 2026 · Related
  21. Recognising errors in AI implementation in radiology: A narrative review · Nikolaos Stogiannos · 2025 · 30 citations · Cited by this paper
  22. AI medical device post-market surveillance regulations: consensus recommendations by the European Society of Radiology · Renato Cuocolo · 2025 · 27 citations · Cited by this paper
  23. The Road Map for ACR Practice Accreditation for Radiology Artificial Intelligence · David B. Larson · 2025 · 15 citations · Cited by this paper
  24. Diagnostic accuracy, fairness and clinical implementation of AI for breast cancer screening: results of multicenter retrospective and prospective technical feasibility studies · Christopher J. Kelly · 2026 · 14 citations · Cited by this paper
  25. AI in Action: A Road Map From the Radiology AI Council for Effective Model Evaluation and Deployment · Hari Trivedi · 2025 · 14 citations · Cited by this paper
  26. Regulating AI Adaptation: An Analysis of AI Medical Device Updates · Kevin Wu · 2024 · 11 citations · Cited by this paper
  27. Real-world performance evaluation of a commercial deep learning model for intracranial hemorrhage detection · Mohammadreza Chavoshi · 2025 · 9 citations · Cited by this paper

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