U-Systems won CE Mark approval in the European Union for its Somo-V automated ultrasound breast cancer screening system.
The Sunnyvale, Calif.-based ultrasound technology firm said the device is intended as an adjunct to mammography to aid in breast cancer detection for physicians diagnosing symptomatic or asymptomatic women, according to a press release.
The company is currently funding the "Somo Insight" clinical study, which it claims to be the largest-ever clinical study by an ultrasound company. It’s designed to evaluate whether digital mammography used with the Somo-V system is more sensitive than routine mammography alone in detecting breast cancer in women with greater than 50 percent dense breast tissue.
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