Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that Hologic has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system. Final approval of the Company's pre-market approval application for the system remains subject to satisfactory review and inspection of our manufacturing facility, methods and controls. The Company plans to work closely with the FDA to complete this final inspection.
"We are extremely pleased to have received the FDA's approvable letter, which represents an important step forward in the commercialization of our Selenia Dimensions tomosynthesis system," said Rob Cascella, President and Chief Executive Officer. "The Selenia Dimensions technology is designed to provide radiologists with enhanced screening and diagnostic capabilities through the incorporation of fast, high-quality 3-D imaging in combination with 2-D imaging. We believe this new technology will address many of the limitations present in stand-alone 2-D imaging and improve upon both sensitivity and specificity. We look forward to working with the FDA to complete the remaining steps in the approval process."
Hologic's Selenia Dimensions 3-D digital mammography system is a new method for breast cancer screening and diagnosis. Unlike prior-generation mammography systems which generate two-dimensional images, breast tomosynthesis produces three-dimensional images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density.
Hologic's Selenia Dimensions 3-D system is available commercially in more than a dozen countries outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico.