FDA Approves First 3-Dimensional Mammography System

Steven Fox

February 14, 2011

February 14, 2011 — The US Food and Drug Administration (FDA) has approved the first mammography system employing 3-dimensional (3-D) imaging, and preclinical studies show that the new technology is 7% more accurate than traditional 2-D mammography in spotting breast tumors.

The new technology is to be marketed as the Selenia Dimensions System and is being manufactured by Hologic, Inc. The system is an upgrade to Hologic's currently available 2-D system.

The system has already been approved in Latin America, Europe, and in Asia.

In approving the device for use in the United States, the FDA assessed results from 2 studies in which radiologists reviewed 2-D and 3-D images from more than 300 mammography studies.

In both studies, radiologists viewing both 2-D and 3-D images were 7% more likely to accurately distinguish between cancerous and noncancerous lesions compared with viewing 2-D images alone.

"Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches," said Jeffrey Shuren, MD, JD, who directs the FDA's Center for Devices and Radiological Health in a press release.

Previous studies have shown that 2-D imaging techniques do not always provide clear images of breast masses, as overlapping skin and other anatomical features can obscure tumors and sometimes create the appearance of a tumor when there is none.

A caveat is that the combination of 2-D and 3-D images approximately doubled the radiation dose to which women were exposed, but the new technology increases efficacy, which presumably will help cut down on the need for follow-up exams. At this time, about 10% of women who undergo 2-D mammography are called back for follow-up X-rays, only to find out later that masses spotted with the 2-D systems are noncancerous.

Mammography Quality Standards require that healthcare professionals undergo 8 hours of instruction before using the new 3-D technology. The FDA also stipulates that the manufacturer provide each user with a manual that defines tests required to maintain quality control.

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