SonoCine Automated Whole Breast Cancer Screening System Receives Approval from Health Canada

RENO, Nev., Jan 17, 2012 (BUSINESS WIRE) -- SonoCine, Inc., the leading innovator of automated whole breast ultrasound (AWBU) screening systems for early detection of breast cancer, announced today that it has been granted a Class 2 Medical Device License by the Medical Devices Bureau of Health Canada to sell and market its Automated Whole Breast Acquisition Screening System (AWBASS) as an adjunct to mammography for screening asymptomatic women for breast cancer.

The SonoCine AWBASS is an accessory to already approved ultrasound scanners, providing computer controlled automatic acquisition and subsequent dynamic review of closely spaced consecutive 2D images of the entire breast and lower axilla. The integration of SonoCine AWBASS and a standard ultrasound scanner forms an Automated Whole Breast Ultrasound (AWBU) screening system.

The SonoCine system received FDA 510(k) clearance in the U.S. in 2008 as an adjunct to mammography, but not a replacement for screening mammography, and in 2010 the results of the first breast cancer screening trial were published in the peer reviewed medical journal, European Radiology.

source: SonoCine