EUREF Type Test Certification Granted to Hologic’s 3Dimensions System

Hologic Inc.’s 3Dimensions mammography system has received EUREF Type Test certification by the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services.¹ 

The company claims the product is the first digital breast tomosynthesis (DBT) system to receive such a distinction, and one of only nine mammography systems overall to earn the certification. The 3Dimensions system features improvements designed to transform the patient experience without compromising on speed, dose or accuracy. It is billed as 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.

“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 EUREF organization works to raise standards by bringing together the best examples of quality control in mammography screening from regional and national breast cancer programs in Europe. The type test certification assures hospitals and imaging centers that 3Dimensions 2D and 3D systems have passed a series of mechanical and clinical tests proving the system meets EUREF’s image quality, radiation exposure and stability standards for screening and diagnostic mammography equipment. Both mammography systems were tested at two clinical sites in the Netherlands for screening and diagnostic uses.
 
Hologic Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being. 

References 
¹ EUREF. Results EUREF Type test. https://www.euref.org/type-test-equipment/euref-type-test-results. Last accessed 15 September 2022
² Data on file and from public sources, 2017
³ Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00119 Rev 003 (2017)