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Post# of 175451
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Thursday, 01/18/2024 10:29:16 AM

Thursday, January 18, 2024 10:29:16 AM

Post# of 175451
Almost a decade into the FDA’s Breakthrough Devices Program (previously the Expedited Access Pathway) and there have been 839 Breakthrough Device designations granted, as of June 30 this year. While that seems a significant number, the FDA also reports that only 81 marketing authorizations have been approved.
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