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Fitting rapidly advancing AI and digital tools into established device regulatory frameworks is a challenge, but that hasn’t stopped policymakers on both sides of the Atlantic from recent efforts to redraw the lines. Experts discuss recent missteps, deregulation, experimentation, and the need for more resources and a new mindset.
MedTech Innovator cohort companies RIVANNA, IMVARIA, and Anumana apply AI-driven solutions across a range of medical specialties.
FDA’s device center touts its accomplishments in advancing global harmonization in FY 2025. Exerpted from Pathways’ Picks February 4: FDA Adopts QMSR, EU Harmonizes Standards, South Korea Spotlights Innovation.