Hologic Gets FDA Nod for 3-D Mammography
Bedford, MA-based Hologic said on Friday it has received approval from the U.S. Food and Drug Administration for its 3-D imaging system for doing breast cancer screening and diagnosis. The company’s X-ray mammography device, called the Selenia Dimensions System, is the first of its kind to provide 3-D images of the breast, according to the FDA. Radiologists in two studies showed a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases when they viewed both 3-D and conventional 2-D images, as compared to 2-D images alone. The idea is that Hologic’s 3-D imaging technology can supplement, not replace, conventional breast scanning. The company’s imaging system is already available in more than 40 countries, including Canada and Mexico.