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The two agencies are rolling out a new path for manufacturers of Breakthrough Devices to collaborate on pivotal trial design and better align FDA authorization to Medicare coverage timelines. This is not the first go-around by FDA and CMS on this type of program, and whether it offers advantages over previous efforts remains to be seen, according to some industry observers.
Three MTI cohort companies seek to add efficiency to various pain points in the practice of collecting medical images.
CMS advances novel payment models in orthopedics. Excerpted from Pathways’ Picks April 15: New Medicare Directions, AI Picks, and Global Regulatory Updates