AIMC Topic: Device Approval
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Evaluating the Impact of the EU AI Act on Medical Device Regulation.
Studies in health technology and informatics
Apr 8, 2025
Artificial Intelligence (AI) is increasingly incorporated into medical devices, revolutionizing diagnostics, treatment planning, and patient monitoring. To ensure AI's safe and ethical use, the European Commission published the AI Act in 2024, which ...
FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.
JAMA
Jan 21, 2025
IMPORTANCE: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication revi...
Challenges and Proposed Additional Considerations for Medical Device Approval of Large Language Models Beyond Conventional AI.
Radiology
Sep 1, 2024
FDA Approves Artificial Intelligence Device for Guiding Regional Anesthesia.
JAMA
Dec 6, 2022
Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions.
Journal of the American Medical Informatics Association : JAMIA
Jun 12, 2021
The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)-driven devices. The exemption is bas...
How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals.
Nature medicine
Apr 1, 2021
Key Principles of Clinical Validation, Device Approval, and Insurance Coverage Decisions of Artificial Intelligence.
Korean journal of radiology
Mar 1, 2021
Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and p...
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