Koning Breast CT receives canadian medical device license
West Henrietta, New York- April 11, 2014- Koning Corporation, a leading developer of advanced medical imaging systems which combine the advantages of Digital X-ray and Computed Tomography called Cone Beam Computed Tomography (CBCT) announced today that they have obtained the Canadian Medical Device License from Health Canada for their Koning Breast CT (KBCT) system and Biopsy Bracket add-on option that enables KBCT-Guided Biopsy. This approval signals that KBCT is in compliance with medical device regulations allowing it to be marketed and sold throughout Canada.
“The Canadian Medical Device License represents a major step for breast-imaging, and women’s health care, in general’ said Ruola Ning, PhD, Koning’s’ President and Founder, a pioneer and leading expert in Cone Beam CT Technology. KBCT is the latest advancement in true 3D breast-imaging technology and focuses on a growing worldwide women’s health issue – the early detection and diagnosis of breast cancer. Breast cancer affects hundreds of thousands of women and is one of the most common forms of cancer in North America, Europe and China. We are very proud to be able to bring this revolutionary technology to benefit Canadian women”.
KBCT is the first commercially available, fully-integrated, dedicated breast CT scanner designed specifically to image the entire breast with high spatial and contrast resolution at a radiation dose similar to or less than diagnostic mammography. The system acquires a set of images in ten seconds producing ‘true’ 3D images and multi-planar cross-sectional slices. Compared to current 2D diagnostic mammography with well recognized limitations, KBCT virtually eliminates tissue overlap and superimposition of structures, which are often responsible for failure to diagnose breast cancer early, when it is most treatable, thereby saving lives and reducing ever growing health care costs.
About Koning
Koning Corporation, founded in 2002, is an International Medical Imaging Company with offices in West Henrietta, New York and Tianjin, China (Koning Tianjin Medical Equipment Co. LTD), developing and marketing “state of the art” Cone Beam CT Scanners for the detection, diagnosis and treatment of diseases and other medical applications. Development of the Koning breast CT technology and system has been supported in part by NIH/NCI SBIR grant (1R44 CA103236), SBIR Bridge Grant (2R44 CA 103236-05) and Federal Government Grant (W81XWH-09-1-0441). These grants benefited from the patents licensed from and developed by the University of Rochester under NIH/NCI grant 1R01CA085904 that developed a concept for cone beam CT, and an exploratory/ developmental 1R21/R33CA094300 grant that explored the cone beam CT concept’s potential for improved breast imaging. Having obtained regulatory approval for Europe in 2012 (CE Mark) Koning’s market focus has been across the pond. The Canadian Medical Device License brings KBCT to North America. Koning Corporation is currently seeking FDA approval in the US and CFDA approval in China.