FDA OKs first 3-D mammography system

By Dow Jones Newswires
Posted Feb. 11 at 1:41 p.m.

The Food and Drug Administration on Friday approved the first three-dimensional mammography system developed by Hologic Inc.  to screen for breast cancer with hopes the device will prove better than current mammography technology.

The device, the Silenia Dimensions System, augments traditional two-dimensional images produced by a mammogram with a 3-D image to be used in breast cancer screening and diagnosis. The system would provide both types of images during a scan so doctors could compare images with previous ones from prior, conventional mammograms.

One problem with a conventional mammogram is that breast tissue overlaps on the image and can obscure small tumors. The FDA said the 3-D images “may help physicians more accurately detect and diagnose breast cancer.”

Hologic’s 3-D device is designed to produce clearer images of the breast and potentially make breast cancer easier to diagnose. It could also reduce the number of women¬† called back for additional screening after undergoing a conventional mammogram. The FDA estimated that about 10 percent of women undergoing a mammogram are called back for additional testing for abnormalities that are non-cancerous.

The company submitted results from two studies that involved radiologists asked to review 2-D and 3-D images from more than 300 mammograms. The FDA said the studies showed doctors obtained a 7 percnet improvement in their ability to distinguish between cancerous and non-cancerous cases using the 3-D images compared to viewing 2-D images alone.

The FDA said the 3-D system increases the radiation dose women receive compared to a traditional mammogram.

According to the National Cancer Institute, about 200,000 women will be diagnosed with breast cancer this year. The survival rate is 98 percent when breast cancer is detected early and still contained in the breast.

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