This white paper from AdvaMed highlights how AI is transforming healthcare through FDA-regulated and unregulated applications. AI enhances diagnostics, treatment planning, and workflow efficiency, with a strong presence in medical imaging. Over 950 AI/ML-enabled devices have FDA approval, most using traditional supervised learning. It also discusses the future role of generative AI and foundation models, their challenges, and regulatory gaps. The FDA’s flexible framework, including the PCCP pathway, supports innovation while ensuring safety. Broader adoption requires alignment on reimbursement, access to quality datasets, and global regulatory harmonization.

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