STAT August 11, 2022
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A boom in breakthroughs
The Food and Drug Administration’s authorizations for innovative devices have significantly accelerated this year, green lighting 11 of its 54 authorized “breakthrough devices” — as many as in all of 2020. The FDA deems “breakthrough devices” as potentially able to offer “more effective” treatment or diagnosis for deadly and debilitating conditions. But until this year, relatively few of the nearly 700 products labeled as such have reached the market.
Recipients get the benefit of more interaction with the agency and expedited review,...
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