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AI/ML Regulatory Masterclass from Orthogonal, UCLA Biodesign and HealthXL

AI & machine learning, FDA

Event Description: For over 10 years, Artificial Intelligence (AI) and Machine Learning (ML) have been radically impacting every industry. Yet it still sometimes seems like it should be so difficult to bring AI and ML to market as a component of FDA-regulated medical devices. Given how deep AI has penetrated into many other industries outside […]

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Article

FDA Software Precertification: A Working Guide for Medical Device Companies 

FDA, SaMD

Recent years, we have seen digital health technologies moving toward rapid adoption in the United States. Yet, Software as a Medical Device (SaMD), mobile medical devices, digital therapeutics (DTx), and Device manufacturers with artificial intelligence (AI) components are often anxious about the lengthy and detailed process of the existing FDA’s premarket review for medical devices. […]

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