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A spotlight on five global medtech policymaking themes that caught our attention in September and October: abundance in China, regulatory recognition and reliance, heart valve market access, electronic submissions and labeling, and regulation of artificial intelligence.
In this month's news, FDA issues 510(k) clearance for a series of AI imaging technologies, EQT buys Qiagen for upwards of $12 billion, Labcorp's acquisition spree, and more.
FDA lends a hand to companies pursuing De Novo authorization. Excerpted from Pathways’ Picks October 21: CDRH Hiring, EU Reform Timeline, AI Policy Plans, and More.