FDA approves first 3-D mammography device
The Food and Drug Administration on Friday approved the first X-ray mammography device that provides three-dimensional images of the breast for breast cancer screening and diagnosis.
The equipment, the Selenia Dimensions System, “could significantly enhance existing diagnosis and treatment approaches” to breast cancer, Jeffrey Shuren, head of FDA’s office of medical devices, said in a statement.
About 10% of women who receive a mammogram require additional testing for issues that ultimately turn out to be non-cancerous. Regulators say the 3-D system may reduce the number of women requiring a second round of testing.
In evaluating the equipment, the FDA reviewed results from two studies in which radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7% improvement in their ability to distinguish between cancerous and non-cancerous cases compared to viewing 2-D images alone, the FDA said in a statement.
The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.
The Selenia Dimensions System is marketed by Hologic Inc, of Bedford, Mass.
