3Dimensions System Earns Distinction for Meeting or Exceeding Rigorous European Image Quality and Dose Standards
, Inc. a global leader in women’s health, announced today that its 3Dimensions™ mammography system was awarded EUREF Type Test certification by the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services (www.EUREF.org
It is the first digital breast tomosynthesis (DBT) system to receive such a distinction, and one of only nine mammography systems overall to earn certification.
The mission of the nonprofit EUREF organisation is to raise standards by bringing together the best examples of quality control in mammography screening from regional and national breast cancer programs across Europe. The type test certification assures hospitals and imaging centers that the 3Dimensions 2D and 3D systems have each passed a rigorous series of mechanical and clinical tests demonstrating that the system meets the image quality, radiation exposure and stability standards set by EUREF for screening and diagnostic mammography equipment. Both mammography systems were tested at two clinical sites in the Netherlands for screening and diagnostic uses.
“The work being done by EUREF contributes greatly to ensuring women receive quality screenings and care across Europe. We are honored to be the first DBT system to meet their rigorous standards,” said Tanja Brycker, Vice President, Strategic Development, Breast & Skeletal Health and Gynaecological Surgical Solutions at Hologic. “EUREF certification is not easy to come by. We are proud that our 3Dimensions system has joined two of our other mammography systems in being recognized. These certifications reflect our commitment to developing high-quality medical technology that improves women’s health.”
The 3Dimensions system features breakthrough improvements designed to transform the patient experience without compromising on speed, dose or accuracy. The system is the fastest, highest resolution breast tomosynthesis system available,2 and is clinically proven to be more comfortable3 for patients while providing an enhanced workflow for radiologists. In addition to this certification, EUREF has previously certified the company’s Selenia® digital mammography and Selenia Dimensions® 2D systems.