The Food and Drug Administration approved Lumicell’s breast cancer imaging tool, the company said Thursday.
Lumicell developed the Lumisystem imaging technology to enable surgeons to detect residual cancer in the breast cavity after performing a lumpectomy to remove the tumor.
An FDA advisory committee voted in March that the benefits of Lumisystem outweigh the risks, with one expert predicting the system will have the biggest impact on surgeons who have higher re-excision rates.