A new study finds that most cardiovascular devices subject to the most serious recalls by the US FDA lacked rigorous clinical testing before approval, raising concerns about patient safety.
A comprehensive analysis of FDA-approved artificial intelligence medical devices reveals significant gaps in clinical validation, raising concerns about their effectiveness and safety in real-world healthcare settings.
The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined its intended policy [1] for recognizing medical device approvals from major regulatory bodies like those in Australia, Canada, the European Union, and the United States.
April 2024
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