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First 3-D mammogram system approved

The US Food and Drug Administration has approved the first X-ray mammography device that provides three-dimensional images of the breast

The US Food and Drug Administration (FDA) has approved the first X-ray mammography device that can provide three-dimensional images of the breast.

The device, Hologic's Selenia Dimensions System, is expected to help reduce the need for women to undergo additional testing after the initial screening exam. About 10 per cent of women who undergo conventional two-dimensional mammography are required to have additional testing for abnormalities that are later determined to be non-cancerous.

The new digital breast tomosynthesis system is an upgrade to Hologic's existing 2D system and can provide both 2D and 3D images. The 3D images help prevent the distortion typically caused by tissue shadowing or density on traditional 2D images of the breast, according to Hologic.

The approval was based in part on two studies in which board-certified radiologists reviewed 2D and 3D images from more than 300 mammography exams. Adding the 3D images to the 2D images resulted in a seven per cent improvement in the radiologists' ability to distinguish between cancerous and non-cancerous tissue.

The combination 2D and 3D mammogram approximately doubles the radiation dose the patient receives. "There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2D and 3D exam is expected to be less than 1.5 per cent compared to the natural cancer incidence, and less than 1 per cent compared to the risk from conventional 2D mammography," according to the FDA.

Hologic said it plans to use Dimensions as a platform technology for launching other imaging modalities related to breast cancer over the next several years.

14th February 2011

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