Company Gets 510(k) for Breast Cancer Radiation Therapy System

Hologic received 510(k) clearance for its MammoSite ML radiation therapy system for the treatment of early-stage breast cancer. The device’s multilumen design allows oncologists to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy, a company statement says. The system allows radiation therapy to be delivered directly to the area where cancer is most likely to recur, allowing a full course of radiation to be administered in just five days.