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Many medical devices deemed 'breakthrough' by FDA are backed by patchy evidence

By STAT News  
   July 02, 2025

At least 127 breakthrough devices have so far come to market, and policymakers now want to take the next step: to make sure that Medicare will pay for them. FDA Commissioner Marty Makary has said that he is working on 'a way Medicare can pay for something the second the FDA approves a breakthrough device.' That's something device makers have been lobbying for, saying it will help them avoid the 'valley of death' that can doom innovative companies before reimbursement kicks in. 

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