Abbott enters the highly competitive TAVR market with its newly CE-marked FlexNav delivery system for Portico.
Abbott Laboratories Inc. announced it has received a CE mark for its FlexNav delivery device for the Portico transcatheter aortic valve replacement (TAVR) system for patients at high or extreme risk for open heart surgery.
Abbott said the FlexNav system offers physicians improved delivery, flexibility and navigation during implant, even in complex cardiac anatomies.
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.
