AIMC Topic: Device Approval
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Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.
JMIR medical informatics
Jul 11, 2025
BACKGROUND: Artificial intelligence/machine learning (AI/ML) has revolutionized the health care industry, particularly in the development and use of medical devices. The US Food and Drug Administration (FDA) has authorized over 878 AI/ML-enabled medi...
[Regulatory classification of AI-enabled products for medical use on the basis of the EU AI Act and MDR/IVDR].
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Jul 4, 2025
The use of artificial intelligence (AI) in healthcare offers great potential but also presents regulatory challenges. The EU Artificial Intelligence Act (AIA), the Medical Device Regulation (MDR), and the Regulation on in vitro diagnostic medical dev...
Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.
JAMA network open
Apr 1, 2025
IMPORTANCE: The primary objective of any newly developed medical device using artificial intelligence (AI) is to ensure its safe and effective use in broader clinical practice.
Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China.
Health policy (Amsterdam, Netherlands)
Feb 1, 2025
The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced...
Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review.
JAMA network open
Jul 3, 2023
IMPORTANCE: The marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical...
An FDA Guide on Indications for Use and Device Reporting of Artificial Intelligence-Enabled Devices: Significance for Pediatric Use.
Journal of the American College of Radiology : JACR
Jul 1, 2023
Radiology has been a pioneer in adopting artificial intelligence (AI)-enabled devices into the clinic. However, initial clinical experience has identified concerns of inconsistent device performance across different patient populations. Medical devic...
Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.
The Lancet. Digital health
Jan 18, 2021
There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governm...
A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior.
Clinical and translational science
Apr 3, 2020
Recent progress in the Internet of Things and artificial intelligence has made it possible to utilize the vast quantity of personal health records, clinical data, and scientific findings for prognosis, diagnosis, and therapy. These innovative technol...
Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.
Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs
Feb 28, 2020
Future development of innovative artificial organs is closely related with cutting edge emerging technology. These technologies include brain machine or computer interface, organs made by three dimensional bioprinting, organs designed from induced-pl...
Early access to health products in France: Major advances of the French "Conseil stratégique des industries de santé" (CSIS) to be implemented (modalities, regulations, funding).
Therapie
Dec 13, 2018
In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, art...
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