British medical device maker BTG PLC and its subsidiary, Biocompatibles Inc., have agreed to pay $36 million to the U.S. government to resolve federal and state False Claims Act (FCA) allegations resulting from the off-label promotion of LC Bead, a medical device approved for use only for embolization of hypervascular tumors. $25 million of the settlement is to resolve the civil qui tam action, which alleged fraud, and $11 million of the settlement is a criminal fine against Biocompatibles.