BEDFORD, Mass., March 24, 2011 /PRNewswire/ -- 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 its Selenia Dimensions digital mammography system in two dimensional (2D) mode has been awarded "EUREF Type Test" certification by the European Reference Organization (EUREF) Council for Quality Assured Breast Screening and Diagnostic Services. Only three products have received EUREF approval to date, of which two are Hologic systems - namely, our Selenia digital mammography system and now Selenia Dimensions, our newest breast cancer screening and diagnosis technology.
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The mission of the non-profit EUREF council is to raise standards by bringing together, at the European level, the best examples of quality control in mammography screening from regional and national breast cancer screening programs. EUREF mammographic type test certification ensures hospitals and imaging centers that the Hologic Selenia Dimensions system in 2D mode has passed a rigorous series of physics and clinical tests demonstrating the system meets the image quality, radiation exposure, and stability standards set by EUREF for screening and diagnostic mammography equipment.
"Hologic has a reputation for following rigorous manufacturing standards and processes including International Organization for Standardization registration and CE mark certification for our Selenia and Selenia Dimensions digital mammography systems," said David Harding, Senior Vice President and General Manager, International at Hologic. "Receiving another EUREF 'Mammographic Type Test' Certification, which is very difficult to achieve, represents a significant milestone for our Company and further distinguishes us from our competition."
"For some time we have been offering our Selenia Dimensions system in 2D and/or 3D mode in our international markets," Harding further noted. "On February 11, 2011 the U.S. Food and Drug Administration (FDA) approved using the Selenia Dimensions system in either or both modes in the U.S. The quality and stability of the system certified by EUREF combined with the recent 3D approval by the FDA sets the Selenia Dimensions breast cancer screening and diagnostic platform in a class of its own."
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications.
Forward Looking Statement Disclaimer
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Selenia Dimensions digital mammography system. There can be no assurance the system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the Selenia Dimensions system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.
Hologic, Dimensions and Selenia are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.
SOURCE Hologic, Inc.