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Published on in Vol 4 (2025)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/76854, first published .
Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Journals

  1. Almarie B, Gonzalez-Gonzalez L, dos Santos Barbosa L, Lutz A, Grosse U, Fregni F. Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting. Biomedicines 2025;13(12):3005 View
  2. Naseer F, Naseer U, Yousaf M, Wei J, Gao Y, Li D, Tian X, Liu Y, Li X, Wang F, Luo P. AI-Integrated biosensors: A paradigm shift in multi-cancer detection with enhanced sensitivity and specificity. Sensors and Actuators Reports 2026;11:100439 View
  3. Bailo P, Nittari G, Pesel G, Basello E, Spasari T, Ricci G. Governing Healthcare AI in the Real World: How Fairness, Transparency, and Human Oversight Can Coexist: A Narrative Review. Sci 2026;8(2):36 View
  4. Xu Q, Li Y, Zhu M, Cai Y, Cheng X, Wang W, Ju J, Xu Y, Liu Y, Liu Y. Precision cardiovascular medicine with big data and AI. npj Digital Medicine 2026 View