Koning Gets FDA Green Light for 3D Breast Imaging System

Medical imaging systems maker Koning said Wednesday that the FDA approved its 3D Koning Breast CT imaging system and KBCT-guided biopsy bracket.

The KBCT is the first 3D breast CT scanner commercially available in the U.S. that images the entire breast with a single scan, according to the Rochester, N.Y., devicemaker. The rapid procedure acquires hundreds of images in 10 seconds, with excellent patient comfort that avoids compressing breast tissue.

Optional accessories include a biopsy bracket to enable KBCT-guided biopsies of suspicious lesions and a collimator used to limit the x-ray beam to the area of interest.  The biopsy bracket delivers 3D targeting at comparable or lower radiation rates compared with stereotactic-guided biopsy, the company said.

Premarket approval was based on more than 680 patient scans. — Kellen Owings