1. Medtech Insight

US Approvals Analysis: Strong Month For IVD De Novos In February

 
• By David Filmore

FDA's increasingly popular de novo classification pathway for moderate-risk devices that have no predicate accounted for five marketing go-aheads last month, four of which were for in vitro diagnostics.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.]

FDA granted market go-ahead for five devices via the de novo classification process in February. That is well above the 1

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