US 510(k) clearance for Macquet's Cardiohelp system
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for the Cardiohelp system developed by Maquet Cardiovascular. The Cardiohelp is the world's smallest portable heart-lung support system providing extracorporeal life support to replace or support a patient's circulation and respiration. US launch is expected later this year, Wayne, New Jersey-based Maquet said. The Cardiohelp can be used as a cardiac and/or respiratory assist device for up to six hours. It is the first support system approved for both ground and air transportation, and allows blood parameters to be monitored during life support, ensuring the patient's safety.
You may also be interested in...
Normality Reasserts Itself For Biotech IPOs
The highs of the COVID-19 era, and the lows that supplanted it, are beginning to fade.
MRM Health Pulls A Pouchitis Hit Out Of The Bag
The mid-stage success is encouraging, but taking on Takeda won’t be easy.
Novartis Draws Out Its APPLAUSE
Another data drop from Fabhalta’s IgAN trial looks encouraging, despite a missing abstract.