Koning has received FDA approval for their new Koning Breast CT (KBCT) system that uses cone bream CT technology to generate high-res 3D images of the breast from the nipple to the chest wall. The system is unique because it does not require compression, which is an uncomfortable necessity in other mammography and ultrasound systems. It was designed to work in tandem with standard 2D mammography, and has proven its efficacy in clinical studies.

The KBCT consists of a horizontal gantry with a patient table where the woman lies prone with her breast positioned in the imaging well. This system does not employ any suction or compression, so the breast retains its natural shape. The breast is separated from contact with the internal mechanisms by a transparent film. The Koning Breast CT was designed for all breast sizes, including very small breasts. The ergonomically-designed patient table and insert enables the breast CT to cover even small breasts. KBCT also includes a guided biopsy needle navigation system, for 3D breast biopsy. In addition, Koning was also able to reduce radiation exposure compared to standard mammography.

Going forward, Koning is investigating how to measure breast density with KBCT, using the brightness of lesions as measured by the Hounsfield unit scale as a possible predictor of malignancy, and whether the device can be used as a screening tool, said John Neugebauer, Koning's senior vice president of sales and marketing.