The U.S. FDA has granted 510(k) clearance to Livanova plc's Lifesparc system, a compact, advanced circulatory support (ACS) pump and controller with ready-to-deploy kits to support a variety of cannulation strategies. The new system replaces the old pump and controller for the company's Tandem system with a streamlined user interface and 40% greater power output and smaller, lighter controller that is half the size of the previous version.

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.