SonoCine has received approval by 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.
AWBASS is designed as an accessory to approved ultrasound scanners to provide computer-controlled automatic acquisition and subsequent dynamic review of consecutive 2D images of the entire breast and lower axilla.
The SonoCine system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2008 as an adjunct to mammography, but not as a replacement for screening mammography.
