The US Food and Drug Administration (FDA) announced that the indications for the MitraClip™, made by Abbott, have been expanded to include secondary mitral regurgitation.
Saranas, Inc, announced that it's Early Bird Bleed Monitoring System for detecting bleeding events during endovascular procedures was granted de novo classification by the US FDA.
European regulators offered decisions on immunotherapies for treating advanced lung cancer, with Roche's atezolizumab and Merck's pembrolizumab receiving approvals for expanded indications from the European Commission, and Pfizer's lorlatinib being endorsed by the European Medicines Agency's drug review panel.
An educational initiative that provided cardiac surgeons with information on their transfusion rates reduced blood utilization without affecting quality measures, a finding that was presented at the recent American College of Cardiology's Cardiovascular Summit in Orlando, Florida.
Researchers in Japan report that the number of operations performed for complex congenital heart disease in Japan increased following the 2011 earthquake and nuclear accident in Fukushima.
Cardiac MRI shows promise for predicting allograft rejection in heart transplant recipients, say researchers from Chicago, Illinois, USA.