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In this week’s Pathways Picks: Former CDRHers launch a venture fund; FDA and industry reach a tentative user fee agreement, and more US agency updates; digital health market access updates from France, England, and Germany; the EU advances breakthrough and orphan pathways; Canada on “significant” change; and more global medtech policy updates.
An update on a company bringing localized, immediate, and beam-free radiotherapy to brain cancer patients.
The number of MDR submissions and certificates is trending up. Excerpted from Pathways’ Picks April 1: AI Act Deemphasized, MDR Numbers, Generative AI Approval, and More.