Breast cancer screening system gets FDA nod

SUNNYVALE, CA – U-Systems has recently announced that its somo*v Automated Breast Ultrasound (ABUS) system has been approved by the U.S. Food and Drug Administration's (FDA) for breast cancer screening. The system is to be used as an adjunct to mammography for asymptomatic women with dense breast tissue. The somo*v ABUS system is currently the only device approved specifically for screening women with dense breasts.

The use of somo*v for screening women with dense breasts will undoubtedly have a positive impact for women currently being underserved by mammography, said Rachel Brem, M.D., director of Breast Imaging at The George Washington University Hospital, Washington D.C.

“Mammography is an effective tool at finding breast cancer, but it doesn't work equally well in everyone. Recently completed studies demonstrated with the addition of ABUS we find about 30% more cancers in women who have normal mammogram, normal physical examination and dense breasts. For the more than 40% of women who have dense breasts, this is a significant advancement in their breast healthcare," Dr Brem said.

The device was approved by the FDA following a unanimous recommendation by the Radiological Devices Panel of the FDA's Medical Devices Advisory Committee for U-Systems' premarket approval (PMA) application in April.

The system can offer radiologists and breast imaging experts an important new tool to improve early detection in women with dense breasts, U-Systems said.

"Enabling radiologists to use the information obtained from mammography and integrate that with the information obtained with ultrasound, leverages the potential of ABUS in a screening environment to find the 30% additional cancers that would not have been found with mammography alone,” said U-Systems president and Research CEO Ron Ho. “With formal approval, we are moving rapidly from development to commercialization and look forward to making the somo*v ABUS system more widely available across the United States.”