According to the company, the LumiSystem allows surgeons to scan the breast cavity post-lumpectomy in real time to detect and resect residual cancer that could have been missed with 84% diagnostic accuracy. The LumiSystem with the company’s LumiSight optical imaging agent is indicated for fluorescence imaging in adults with breast cancer as a supplement for the intraoperative detection of cancerous tissues within the resection cavity after removing primary specimens during lumpectomy surgery.

“We are immensely proud of the dual approval of LumiSystem and Lumicell DVS – we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes,” President and Chief Operating Officer Howard Hechler said in a news release. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.”