Since the Food and Drug Administration launched its breakthrough device program in 2016, it’s tapped more than 1,000 products with the label. The goal: to get innovative devices reviewed faster, and in the hands of patients with serious illnesses and unmet medical needs. 

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. 

Before making that call, clinicians and researchers have argued, it’s important to understand whether the breakthrough program is living up to its name. “Are these so-called breakthrough devices really breakthroughs?” asked Kushal Kadakia, a resident at Massachusetts General Hospital who studies medical device regulation.

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