FDA’s AI Device Guidelines Evolve: How Medtech Can Adapt

FDA’s AI Device Guidelines Evolve: How Medtech Can Adapt

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FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing comprehensive lifecycle guidance for AI-enabled software, tightening cybersecurity obligations, and expanding real-world evidence (RWE) use. Medtech manufacturers who ‘bite the bullet’ now investing in GMLP, bias mitigation, secure-by-design update infrastructure,…

How the FDA’s stance on breakthrough AI is evolving

How the FDA’s stance on breakthrough AI is evolving

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A lot of artificial intelligence tools in medicine pitch themselves as breakthroughs. But there are some that can put some extra oomph behind that claim. Since 2016, the Food and Drug Administration has handed out “breakthrough” designation to more than 1,200 devices, including many powered by AI. The designation comes with priority FDA review, with…