3-D Mammography Device Approved by FDA
The first 3-D mammography device has been approved by the Food and Drug Administration.
The device provides three-dimensional images of the breast making it easier to diagnose and screen for breast cancer.
Regulators say the 3-D system may reduce the amount of testing. About 10 percent of women require additional testing for the issue to turn out to be non-cancerous.
The FDA approved the Selenia Dimensions System, the first mammography device to generate 3-D images, on Friday. The system is from Hologic Inc. and offers both 2-D and 3-D X-ray images, which provide additional viewpoints of the breast.
"Physicians can now access this unique and innovative 3-D technology that could significantly enhance diagnosis and treatment approaches," said Jeffrey Shuren, director of the FDA's device division, in a statement.
Approximately one in eight women will be diagnosed with breast cancer in her lifetime, according to the National Cancer Institute. It is recommended that women ages 40 and older have a mammogram every one to two years.