Breast CT developer Koning has received Canadian regulatory approval for its breast CT scanner, the firm's first clearance in North America.
Now that the Koning Breast CT (KBCT) scanner has received the Canadian medical device license from Health Canada, it can be sold throughout the country. The scanner is designed to image the entire breast with high spatial and contrast resolution, using radiation doses similar to or less than those of diagnostic mammography, Koning said.
KBCT acquires a set of images in 10 seconds, producing 3D images and multiplanar cross-sectional slices. Compared with current 2D diagnostic mammography, KBCT virtually eliminates tissue overlap and superimposition of structures, which can lead to a missed early breast cancer diagnosis when the disease is at its most treatable stage, according to the firm.
The approval also covers a biopsy bracket add-on option that enables the KBCT scanner to be used for image-guided biopsy.
