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FDA clears new version of Hologic's Mammosite

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for Hologic's MammoSite ML radiation therapy system, a targeted breast cancer treatment. The device is a new version of the company's single-lumen MammoSite system, which was first cleared in the US in 2002. MammoSite ML has a multi-lumen design, which allows oncologists to better target the radiation dose. This enables treatment of patients who would otherwise not be candidates for traditional brachytherapy, such as those with tumours close to the skin or chest wall, Bedford, Massachusetts-based Hologic said. Both systems are comprised of an inflatable balloon catheter which is inserted into the cavity created by a lumpectomy, and through which radiation is delivered.

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