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. Read More
With an eye toward helping patients with chronic kidney disease (CKD) receive earlier interventions, Fresenius Medical Care North America (FMCNA) has made an investment in Biointellisense Inc., of Denver. Biointellisense is developing a medical grade data services platform for continuous health monitoring, predictive analytics and algorithmic clinical insights. Read More
