Healthcare AI in the United States — navigating regulatory evolution, market dynamics, and emerging challenges in an era of rapid innovation

Healthcare AI in the United States — navigating regulatory evolution, market dynamics, and emerging challenges in an era of rapid innovation
Mondaq; by Jones Walker; 10/7/25
... As 2025 progresses, the convergence of technological innovation, regulatory adaptation (or lack thereof), and market shifts has created remarkable opportunities and complex challenges for healthcare providers, technology developers, and federal and state legislators and regulatory bodies alike. The rapid proliferation of AI-enabled medical devices represents perhaps the most visible manifestation of this transformation. With nearly 800 AI- and machine learning (ML)-enabled medical devices authorized for marketing by the US Food and Drug Administration (FDA) in the five-year period ending September 2024, the regulatory apparatus has been forced to adapt traditional frameworks designed for static devices to accommodate dynamic, continuously learning algorithms that evolve after deployment.