AIMC Topic: Medical Device Legislation
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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...
Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation.
European journal of health law
Sep 14, 2021
In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade ...
The EU medical device regulation: Implications for artificial intelligence-based medical device software in medical physics.
Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB)
Feb 28, 2021
Medical device manufacturers are increasingly applying artificial intelligence (AI) to innovate their products and to improve patient outcomes. Health institutions are also developing their own algorithms, to address specific needs for which no comme...
Machine Learning Systems Applied to Health Data and System.
European journal of health law
May 19, 2020
The use of machine learning (ML) in medicine is becoming increasingly fundamental to analyse complex problems by discovering associations among different types of information and to generate knowledge for medical decision support. Many regulatory and...
Innovative Technologies in Healthcare, Beware of the Pitfalls.
European journal of health law
Feb 13, 2020
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 ...
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