MammoSite ML Radiation Therapy System Cleared for Treating Early-Stage Breast Cancer
Hologic, Inc, recently announced the US Food and Drug Administration (FDA) cleared the Company’s 510K application for the MammoSite ML radiation therapy system. With its multilumen design, this new device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.
Hologic, Inc, recently announced the US Food and Drug Administration (FDA) cleared the Company’s 510K application for the MammoSite ML radiation therapy system. With its multilumen design, this new device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.
Hologic’s MammoSite therapy system, first cleared by the FDA in 2002 as a single-lumen device, is the most widely used form of accelerated partial-breast irradiation (APBI) in the United States.
Hologic expects to commercially launch MammoSite ML during the first quarter of fiscal year 2010 (quarter ending December 26, 2009).
