The CE Marks recorded in October include Abbott's new version of Xience and Medinol's BioNIR drug-eluting coronary stents, plus 18 other devices approved in eight different territories.
[Editors' note: For sortable and searchable tables of all US and non-US approvals and clearances in 2017 and previous years, check out our Approvals Tracker.]
Abbott Laboratories Inc. announced Oct. 30 that it received a CE mark for XienceSierra, the fifth generation of the company's highly successful Xience everolimus-eluting coronary stent line.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
