(September, 2016 – From Monteris Medical) PLYMOUTH, Minn. Monteris Medical announced the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) to evaluate the NeuroBlate® System in patients newly diagnosed with glioblastoma multiforme (GBM). With this approval, Monteris will initiate the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Newly Diagnosed GBM (FLAG), an open-label, prospective study that will be conducted in five sites in the United States.
Monteris Medical is a spinoff company of St. Boniface Hospital Research. For more information on this exciting development at Monteris, read the full press release here: