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FDA Approves Hologic’s 3-D Mammography Device

February 12, 2011

The US Food and Drug Administration on Friday said it had approved a mammography device that shows 3D images of the breast with the hopes that the new technology will improve early breast cancer detection.

The new system, called Selenia Dimensions System from Bedford, Massachusetts-based Hologic Inc., offers 2D and 3D X-ray images, providing doctors and patients with a better view of the breast and what may be going on inside.

The FDA said the new tool doubles the amount of radiation exposure to the patient, but will also increase the accuracy of diagnosing tumors. As a result, fewer women should have to undergo multiple scans.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance diagnosis and treatment approaches,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told AFP in a statement.

In two different studies, X-ray specialists demonstrated a 7 percent improvement in spotting cancerous tumors when using Hologic’s 3D device, which helped the FDA make its decision on an approval for the system.

Current 2D imaging can leave tumors hard to find due to overlapping skin, which can hide tumors or create the appearance of tumors where there are none.

Approximately one in eight women are diagnosed with breast cancer, according to figures from the National Cancer Institute. It recommends women 40 and older have a mammogram every one or two years.

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