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FDA plans to exempt more unclassified devices from premarket notification requirements. Excerpted from Pathways’ Picks June 11: Opposition to EU WET Exemptions, Medicare Coverage Updates, and More.
Health ministers push for changes and action on MDR/IVDR reforms. Excerpted from Pathways’ Picks June 17: EU Health Ministers Weigh Reforms, UK-US Liaisons, and TAVR Milestone.
The former CDRH Director is joining the MedTech Innovator accelerator as an advisor. Excerpted from Pathways’ Picks June 24: Devices Selected for EU Tech Assessments, Breakthrough Pilot, and More Medtech Policy Picks.
Medicare’s phased-in elimination of the inpatient only rule and simultaneous expansion of the list of procedures it covers in ambulatory surgery centers are forcing medical device manufacturers to rethink where and how much they get paid.