Three-Dimensional Mammography Approved

The FDA has approved enhancements to a conventional mammography system to enable delivery of three-dimensional views for breast cancer screening and diagnosis, the agency announced Friday.

In clinical studies involving some 300 mammograms, the enhancements allowed a 7% improvement over standard two-dimensional views in distinguishing between cancers and noncancers. The agency says using a combination of 2-D and 3-D images doubles the radiation dose delivered but increases cancer risk by less than 1%, compared with conventional mammography. The number of women recalled for diagnostic work-up was significantly lower with the 3-D enhancements, according to manufacturer’s documents filed with the FDA.

Source: FDA

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