Improved Molecular Breast Imaging Screening System Receives CE Marking

A breast imaging medical device manufacturer has announced that their Molecular Breast Imaging (MBI) system, intended for women with dense breast tissue, has received the European CE Marking.

The MBI screening system is already in use in leading hospitals in the US following approval by the US Food and Drug Administration (FDA) in 2011. The system is intended for the screening and early detection of breast cancer in women with dense breast tissue for whom conventional mammography and screening with other modalities is insufficient.

CE Marking approval of the LumaGEM MBA screening system was announced by the manufacturer, Gamma Medica (Salem, NH, USA), a women’s health company, and enables the company to sell and distribute the system in the European Economic Area (EEA).

Nearly one in 10 women in Europe develops breast cancer before the age of 80, making it the common cancer affecting women. Conventional mammography has less sensitivity when imaging dense breast tissue – both dense tissue and cancerous areas appear white on the mammogram. At the same time women with dense breast have an increased risk of developing breast cancer. A recent has shown that the addition of MBI screening test to an annual mammogram resulted in a nearly 400% percent increase in detection rates of invasive breast cancer. The use of MBI screening also resulted in 50% less biopsies, and cost savings of 15% per cancer detected, compared to only screening with conventional mammography.

MBI is a functional imaging modality and can show activity and detect tumors in dense tissue, whereas other modalities such as ultrasound, Magnetic Resonance Imaging (MRI), and tomosynthesis, are anatomical imaging systems. MBI is also useful for high-risk patients, and those who cannot undergo an MRI exam.

Philip M. Croxford, President and CEO of Gamma Medica, said, “Securing the CE Mark for the LumaGEM MBI system represents a major step forward in our commercialization plans to market this technology to benefit women with dense breast tissue in Europe. By offering the best MBI solution to physicians, we are helping them manage their patients’ risk efficiently by providing a highly accurate and cost-efficient secondary breast cancer screening for women with complex mammograms and dense breast tissue.”

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Gamma Medica