The FDA's draft guidance, "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations", represents a significant step toward addressing the complexities of AI in...
Introduction Advancements in Artificial Intelligence (AI) and Machine Learning (ML) are paving the way for transformative innovations in healthcare, particularly in breast cancer detection. Recent studies...
Introduction Emerging technologies are transforming the medical device landscape, bringing unique AI/ML regulatory challenges and opportunities for SaMD compliance. Innovations like Software as a Medical Device...
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