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Companies were caught off guard by CMS’ recent proposal to end a simplified path to add-on payments for FDA Breakthrough Devices. Industry is urging the agency to rethink its plan or at least slow it down to avoid undercutting firms that pursued clinical development for breakthrough-designated devices based on the current policy.
In this month's news, FDA clearances for several imaging technologies, Resmed expands into sleep medicine by buying Noctrix Health, TAP pilot progress, 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.