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FDA OKs new 3-D breast scan, risks unclear

U.S. health officials have approved Hologic Inc's 3-D mammogram system in hopes that it may help doctors better detect and diagnose breast cancer, even though women may be exposed to more radiation.
/ Source: Reuters

U.S. health officials have approved Hologic Inc's 3-D mammogram system in hopes that it may help doctors better detect and diagnose breast cancer, even though women may be exposed to more radiation.

The device, an upgrade to the company's already approved 2-D system, offers physicians a more detailed look at the breast to see any possible anomalies, the Food and Drug Administration said on Friday.

Shares of Hologic were up 1.3 percent at $19.98 in afternoon Nasdaq trading after the news.

Traditional mammograms are still the best way to find breast cancer, the FDA said in a statement, but the limited technology requires some women to have additional testing. Reviewing an additional 3-D image helped doctors find more cancers than with 2-D images alone, it said.

However, the additional 3-D testing does double the amount of radiation given to patients and "there is uncertainty for radiation risk estimates," FDA said.

Still, the more-detailed scans "improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic work-up."