FDA Panel Recommends Approval for U-Systems Automated Breast Ultrasound System
U-Systems has announced FDA's Radiological Devices Panel of the Medical Devices Advisory Committee has recommended approval of its somo•v Automated Breast Ultrasound system, according to a news release (pdf).
U-Systems is seeking a breast cancer screening indication for the system, which is currently FDA-cleared for diagnostic use as an adjunct to mammography.
If the system receives premarket approval, U-Systems said it would the only ultrasound device in the United States approved for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.
"With the positive FDA panel review of the somo•v for breast cancer screening, we now have the opportunity to integrate 3D automated breast ultrasound screening into clinical practice, which will enable us to find previously undetectable cancers," said Rachel Brem, MD, director of breast imaging at The George Washington University Hospital in Washington, D.C. "Mammography is an effective tool at finding breast cancer, but it doesn't work equally well in everyone. In women with dense breasts, we can’t see over a third of breast cancers, so we need other technologies, other approaches."
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