US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals

The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.

FDA approved background, 3D rendering, blue street sign

[Editors' note: Check out our 2016 Medical Product Approvals infographic [hyperlink] and our analysis of 2016 approval trends outside of the US. For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.]

2016 was another historically productive year in US FDA approvals of novel devices or major new indications.

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