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In the latest update on the FDA’s Breakthrough Devices program, the agency said that 56 medical devices that received breakthrough designations have gone on to gain marketing authorizations as of Sept. 30. Read More
The FDA grants the De Novo classification to devices for which there are no comparable products already on the market that meet the same clinical need. Read More
An FDA advisory panel has voted 11-2 against approval of SOLVD Health’s De Novo request to market AvertD, a genotype test to identify patients at increased risk of opioid use disorder (OUD). Read More