For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year.
The Food and Drug Administration is on track to top its previous records, offering expedited regulatory consideration — and if medical device companies have their way, a streamlined path to insurance coverage — to dozens of novel tools.
As a STAT investigation earlier this year revealed, while the program was designed to speed access to new diagnostics and therapeutics for patients in need, it has delivered its most obvious benefits to the device industry. Companies can trade on the prestige of a designation, which can be based on limited evidence, long before devices have been authorized for marketing. A Trump-era rule would have also guaranteed four years of Medicare coverage for authorized breakthrough devices, which led many companies to race to apply for the status.
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