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With their newly proposed RAPID pathway, FDA and CMS say companies can work with them to design a pivotal trial that will address regulatory authorization and national Medicare coverage. Stanford’s Josh Makower and TCET architect Steve Farmer debate if that is doable.
Three MTI cohort companies seek to add efficiency to various pain points in the practice of collecting medical images.
User fees would bankroll more than half of the FDA’s FY2027 budget request. Excerpted from Pathways’ Picks April 7: Shuren Venture Fund, MDUFA Agreement, Global Digital Health Updates.