Hologic’s Breast Imaging Software Gains Additional Indications

Bedford, Mass.-based Hologic Inc., provider of diagnostics, medical imaging systems and surgical products for women’s health, has received U.S. Food and Drug Administration (FDA) approval for its C-View 2-D imaging software. Images generated by C-View now can be used in place of the conventional 2-D exposure previously required as part of a Hologic 3-D mammography (breast tomosynthesis) screening.

C-View images are generated from 3-D tomosynthesis data acquired during a mammography, purportedly eliminating the need for additional 2-D exposures. The combination of Hologic’s 3-D and C-View 2-D images are designed to reduce time under compression, which is thought to increase patient comfort and reduce radiation exposure, while still providing the 2-D images required as part of Hologic’s FDA approved 3-D mammography screening exam. According to the company, clinical studies have shown that screening with Hologic’s 3-D mammography technology using C-View imaging results is better than a conventional 2-D mammogram.

“Approval of our C-View software is an important evolution in Hologic’s 3-D mammography screening program. Eliminating the need for additional 2-D exposures will provide a better experience for patients,” said Peter Soltani, senior vice president and general manager of Hologic’s Breast Health business. “C-View software was developed to provide yet another option to imaging centers to improve patient care and clinical outcomes. Large-scale clinical studies have shown that screening with Hologic’s 3-D mammography technology allows radiologists to visualize the breast in greater detail than with 2-D mammography alone, which results in earlier detection of cancers while at the same time reducing the false positives associated with conventional 2-D mammography that cause unnecessary anxiety and cost.”

Hologic’s 3-D mammography technology was CE Mark-approved in 2008. It was approved for use in the United States for breast cancer screening and diagnosis in 2011. C-View 2-D imaging software has been commercially available in Europe and many countries in Latin America and Asia since 2011. Hologic expects to begin shipments in the United States in June 2013.