In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, ...
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device ...
In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...
AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at $10.31 billion in 2023, is forecasted to reach $14.92 billion in 2024 and ...
FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...
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