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US Approvals Analysis: Molecular Dx Innovations Make Waves In November

 
• By David Filmore

Four novel molecular diagnostics, including two next-generation sequencing platforms, gained FDA approval in November, almost half of the nine novel-device approvals last month. The agency was also active with PMA supplement approvals and 510(k) clearances during the period.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all US and global approvals and clearances in 2017 and previous years, check out our Approvals Tracker. Look out for our November analysis of approvals from other regions in the world later this week.]

Novel molecular diagnostics had a good showing in FDA approvals last month. There were two highly-touted approvals of next-generation sequencing technologies that relied on novel review pathways, and two DNA-based...

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