Breast Cancer Detection Drug-Device System Nabs FDA Approval

Recently, Lumicell, a company focused on the development of fluorescence-guided imaging technologies for cancerous tissue detection during surgery, announced FDA approval of its New Drug Application (NDA) for Limisight (pegulicianine) optical imaging agent and Premarket Approval (PMA) for Lumicell Direct Visualization System (DVS), together referred to as the LumiSystem. FDA approved the two products to assist in breast cancer detection within, “the resection cavity following removal of the primary specimen during lumpectomy surgery,” according to the agency.