FDA approves first 3-D mammography device

WASHINGTON -- A system for producing three-dimensional mammograms, approved for the first time by the Food and Drug Administration on Friday, could reduce the number of women who require additional screening for breast cancer.
But experts and advocacy groups were divided over how helpful the new X-rays may prove to be. Once the technology becomes widely available, it would presumably reduce the number of initial mammograms that yielded inconclusive results and thus reduce follow-up tests. Whether that would reduce the overall incidence and deaths from breast cancer is not clear.
Today, breast cancer claims the lives of some 40,000 annually in the U.S., even though the survival rate is 98 percent when the disease is detected early and still localized to the breast.
The FDA approved the Selenia Dimensions System, marketed by Hologic Inc., of Bedford, Mass, which produces both conventional digital 2-D mammography images and 3-D images. The FDA approval specifically requires that 3-D images be taken in tandem with 2-D images.
The dual images are required because that's the way Hologic designed studies showing the effectiveness of its technology, according to FDA spokeswoman Erica Jefferson.
"As technology improves and radiologists become more familiar with the 3-D imaging technology, the FDA could be in a position to approve a device that is just intended for 3-D imaging," Jefferson said.
Hologic spokesman Jim Culley said the company sought a combined 2-D and 3-D approval because it recognized that doctors have spent years learning to read 2-D images and didn't want to introduce a completely new system.
"We wanted to make this as easy as possible, said Culley, who said the device already is approved in 40 countries.
About 10 percent of women require follow up screening because their first set of mammograms is not clear enough, something 3-D images might help resolve, said Kristin Byrne, chief of breast imaging for New York's Lenox Hill Hospital.