AIMC Topic: Device Approval
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The Role of the FDA in Ensuring the Safety and Efficacy of Artificial Intelligence Software and Devices.
Journal of the American College of Radiology : JACR
Oct 30, 2018
Robotic surgery: new robots and finally some real competition!
World journal of urology
Feb 9, 2018
PURPOSE: For the last 20 years, the predominant robot used in laparoscopic surgery has been Da Vinci by Intuitive Surgical. This monopoly situation has led to rising costs and relatively slow innovation. This article aims to discuss the two new robot...
Role of AI in Clinical Decision-Making: An Analysis of FDA Medical Device Approvals.
Studies in health technology and informatics
Aug 7, 2025
The U.S. Food and Drug Administration (FDA) plays an important role in ensuring safety and effectiveness of AI/ML-enabled devices through its regulatory processes. In recent years, there has been an increase in the number of these devices cleared by ...
Navigating FDA Regulations for the Development of Artificial Intelligence Technologies in Plastic Surgery.
Aesthetic surgery journal
Jul 15, 2025
Artificial intelligence (AI) technologies are rapidly transforming the field of plastic surgery, offering new opportunities for improving patient outcomes through enhanced diagnostic capabilities, personalized treatment planning, and outcome predicti...
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...
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