Hologic's Selenia Dimensions 3-D digital mammography tomosynthesis system is presently commercially available outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional only system that can be upgraded to do breast tomosynthesis (3-D) imaging when and if the product is approved by the FDA.
"We are extremely pleased with the outcome of today's FDA Panel meeting," said Rob Cascella, President and Chief Executive Officer. "Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2-D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection - fast, high-quality 2-D and 3-D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women's lives."
SOURCE Hologic, Inc.