Advanced Breast CT System and Biopsy Bracket Receive US FDA Approval

The KBCT system completed the FDA medical device Pre-Market Approval (PMA) process.

The KBCT acquires a large number of images in a short time producing 3-D images for breast diagnosis. The system claims to be the first commercially available 3-D breast CT scanner which can image the whole breast, without compression, in a single scan. The KBCT biopsy bracket also received FDA approval and enables KBCT-guided breast biopsies of suspicious lesions. In addition, a collimator limits the X-ray beam to the area of interest resulting in reduced radiation exposure than stereotactic guided biopsy systems.

The KBCT is produced by Koning Corporation (West Henrietta, NY, USA), a leading developer of advanced medical imaging systems.

Ruola Ning, PhD, Koning's President and Founder, commented, "This FDA approval represents a major step forward for breast imaging and women's health care. KBCT represents a revolutionary advancement in breast cancer diagnosis. Breast cancer is a growing worldwide women's health issue impacting hundreds of thousands of women."

Related Links:
Koning
FDA