FDA Approves New Device to Screen Dense Breasts

September 19, 2012

The FDA has approved a new ultrasound device to detect breast cancer in women with dense breasts. It will be used in conjunction with standard mammography in asymptomatic women with a negative mammogram.

The FDA has approved a new ultrasound device, the somo-v Automated Breast Ultrasound System (ABUS), to detect breast cancer in women with dense breasts. It will be used in conjunction with standard mammography in asymptomatic women with a negative mammogram.

The device has a specially shaped transducer that scans the whole breast in 1 minute, and produces multiple images, according to the FDA.

In a test conducted by U-Systems, the product’s manufacturer, 200 asymptomatic women with dense breasts were examined by radiologists, with some screened with traditional mammography and some screened with both mammography and the somo-v ABUS. The use of supplemental ultrasound images increased breast cancer detection by nearly 30%.

And FDA advisory committee unanimously voted to approve the device, but stated that women with previous breast surgeries or biopsies should not generally be screened with the device, since the breast tissue may be altered, increasing the chance of a false positive result.