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Le système de la mammographie de Hologic gagne la certification européenne

par Heather Mayer, DOTmed News Reporter | June 24, 2010
Hologic Selenia
Hologic Inc., dedicated to women's health technology, has been granted European certification for its Selenia mammography system. The Hologic system is the first mammography system of any type to receive this certification.

After a lengthy and rigorous application process, the European Reference Organization Council for Quality Assured Breast Screening and Diagnostic Services granted the company's tungsten tube-based digital mammography system "mammographic type test" certification.

This voluntary European certification is much more difficult to achieve than the traditional CE mark approval, says Jim Culley, Hologic's director of marketing. The CE approval only takes into consideration electrical safety, environmental safety and whether the system does what the manufacturer says it will do. But the EUREF certification, going further, only approves systems that meet "ideal" standards, Culley tells DOTmed News.

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"[It] really is a cool thing," he says.

The Selenia system has been marketed in Europe and the United States for years. Currently, Hologic is awaiting approval for another of the company's mammography systems.