WAYNE, Pa., April 01, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced FDA 510(k) clearance of the AC3 Range™ Intra ...

Compared with standard medical care, early use of a temporary intra-aortic balloon pump (IABP) to support heart function in patients who were critically ill with cardiogenic shock caused by heart ...

Compared with standard medical care, early use of a temporary intra-aortic balloon pump (IABP) to support heart function in patients who were critically ill with cardiogenic shock caused by heart ...

The CE certificate for the Cardiosave balloon pump remains suspended, potentially affecting future sales and market confidence. The company faces elevated quality-related costs, trending above SEK0.5 ...

In cardiac systems, one of the main product lines is Cardiosave, its IABP system which helps the heart pump blood during hospitalization.

"We have decided to immediately pause promotional activities of the Cardiohelp System and Cardiosave Intra-Aortic Balloon Pump in the U.S. until outstanding actions related to quality improvements ...

In the letter from the U.S. FDA, there are no new field actions referred to, but healthcare providers are advised to transition from Getinge's Cardiosave Intra-Aortic Balloon Pump (IABP), Cardiohelp ...

For markets outside the U.S., Getinge has implemented product improvements, and will continue to sell Cardiosave IABP and the Cardiohelp System as well as continue to provide intra-aortic balloon ...

What is Official Development Assistance? Official Development Assistance or ODA is the formal name for what is more commonly known as foreign aid. The term covers flows of humanitarian and development ...

The Swedish medical-technology company said Tuesday that it would immediately pause promotional activities on its Cardiohelp System and Cardiosave IABP in the U.S. until certain quality ...

The FDA suggests providers to move away from the use of Getinge's Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and its Cardiohelp system and HLS Sets.