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In this week’s Pathways Picks: UK floats legislation that could lead to direct MHRA device reviews, rather than third-party assessments; FDA signs a memorandum of understanding with the Securities and Exchange Commission; China issues 100-plus draft device-specific guidance documents in one day; and more global medtech policy updates.
At a NASS Summit on Spine Innovation, battle-hardened entrepreneurs, surgeons, investors, and healthcare system executives discussed lessons learned and takeaways for building companies in a financially constrained environment.
FDA proposes a “competency” framework for regulating generative AI; Excerpted from Pathways Picks August 19: FDA GenAI Plan, Commish Nom, Global Picks, and More.