Market Pathways covers the people, challenges, and opportunities impacting the global medtech regulatory, reimbursement, and policy communities. We invite you to explore our coverage. Think Strategically.
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As Democrats get set to take control of both chambers of Congress, medtech looks for reauthorization of FDA user fees and more. The power shift in Washington, DC is significant, but its impact on medtech is unpredictable.
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 week’s Pathways Picks: FDA considers autonomous and remote robots, adds flexibility to emergency diagnostic testing, and proposes 510(k)s for more companion diagnostics; medtech and the midterms; CMS delays remote monitoring payment restrictions, finalizes pass-throughs, and adds DME latitude; EU adopts updated standards and makes a pact with Singapore; and more global policy updates.