Gamma Medica said it won CE Mark approval in the European Union for its LumaGEM molecular breast imaging system.
The device is designed to eliminate shortcomings in mammography systems for women with dense breast tissue, which Salem, N.H.-based Gamma Medica said make up approximately 50% of all women.
Dense breast tissue has been linked to an increased risk of breast cancer and decreased mammography sensitivity, 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,” CEO Philip Croxford said in a press release.
The system won FDA premarket approval in 2011, and is commercially available in the U.S., the company said.
In June, Gamma Medica said it replaced CEO Jim Calandra, who left to “pursue other opportunities,” with former LifeCell CEO Philip Croxford. The company also said it named Toshiba America Medical Systems vet Scott Headland as its new vice president of sales.