3D Mammography System Approved

March 4, 2011

The first x-ray mammography device that provides three-dimensional (3D) images of the breast has gained FDA approval.

The first x-ray mammography device that provides three-dimensional (3D) images of the breast has gained FDA approval. The agency said the Selenia Dimensions System, which uses the process of tomosynthesis, might help physicians more accurately detect and diagnose breast cancer.

Currently, about 10% of women screened with conventional two-dimensional (2D) mammography undergo further testing for abnormalities that prove to be benign, the FDA said in its February 11 announcement. Before approving the 3D system, the FDA looked at 2 studies where radiologists reviewed 2D and 3D images from >300 mammograms. The 3D images resulted in a 7% improvement in the radiologists’ ability to distinguish between cancerous and benign cases.

The Selenia Dimensions System is a flexible platform that can be used as an add-on to a traditional digital mammography system, with the ability to move between imaging modes, according to the manufacturer, Hologic, Inc, headquartered in Boston, Massachusetts. For further information, visit the FDA at http://tiny.cc/7ok9f or the company site at http://tiny.cc/f89am.