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www.fdanews.com/articles/173546-gamma-medica-receives-ce-mark-approval-for-breast-imaging-system

Gamma Medica Receives CE Mark Approval for Breast Imaging System

October 12, 2015

Salem, N.H., devicemaker Gamma Medica received CE mark approval for its LumaGEM molecular breast imaging system, clearing the way for sales and distribution within the European Economic Area.

The system aids in early detection of breast cancer for the 50 percent of women who have dense breast tissue, which is often not picked up by mammography and other cancer screening modalities.

In a recent Mayo Clinic study, use of molecular breast imaging systems, such as the LumaGEM, led to a 400 percent increase in invasive breast cancer detection rates, 50 percent fewer biopsies and 15 percent lower cost per case detected than mammography alone, the company says.

The FDA approved the system in 2011. — Michael Cipriano