Hologic Inc. landed 510(k) approval from the Food & Drug Administration for its MammoSite ML radiation therapy system, saying it plans to bring the device to market during the first quarter of fiscal 2010, which begins in October.
The Bedford, Mass.-based women’s health products maker said the device’s multi-lumen design gives radiation oncologists the ability to shape the dose for breast cancer patients, delivering targeted radiation therapy directly to the area where cancer is most likely to recur.
That means a full course of radiation can be delivered in five days; the device also limits radiation exposure in healthy tissue. It’s aimed at women who may not be good candidates for traditional brachytherapy.