Hologic scores 510(k) for MammoSite ML

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The FDA has approved Hologic’s 510K application for the company's MammoSite ML radiation therapy system.

With its multi-lumen design, the Bedford, Mass.-based company said the new device allows radiation oncologists to shape the radiation dose for typical cases and treat patients who are not appropriate candidates for traditional brachytherapy.

Hologic said its MammoSite therapy system, first cleared by the FDA in 2002 as a single-lumen device, allows for the delivery of accelerated partial breast irradiation. The MammoSite systems are comprised of an inflatable balloon catheter in which a radioactive source is introduced for therapy delivery. The inflatable balloon is inserted into the surgical cavity and remains after tumor removal, according to the company.