US Approvals Analysis: Biotronik Making Its Interventional Mark

The German-headquartered firm is making a play to enter the US vascular intervention market, with two stents approved by FDA under original PMAs in the first quarter of 2017. Cardiovascular devices, in general, have gained the most novel-device approvals so far this year, followed by IVDs. Check out more from a Q1 look at US FDA approvals and clearances monitored by Medtech Insight's Approvals Tracker.

FDA approved background, 3D rendering, blue street sign

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

After one quarter, Biotronik SE & Co. KG is leading in 2017 novel device approvals (original PMAs, panel-track supplements and de novo classifications) in the US

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