FDA Approves 3D Breast CT

The U.S. Food and Drug Administration (FDA) has approved the Koning Breast CT (KBCT) and KBCT-guided biopsy bracket, Koning Corporation announced.

KBCT is the first commercially available 3D breast scanner designed to image the entire breast with a single scan and no compression of the breast tissue, Koning said in a release. The procedure is quick, it takes 10 seconds for the system to acquire hundreds of images, Koning said.

The KBCT comes with optional accessories including a biopsy bracket to enable KBCT-guided breast biopsies of suspicious lesions with 3D targeting at comparable or lower dose compared to stereotactic guided biopsy, and a collimator, used to limit the X-ray beam to the area of interest, Koning announced.

“The results we have been with 3D-KBCT have been remarkable compared to 2D imaging and there is no compression of the tissue making breast CT a much more comfortable and painless procedure for women. I believe that 3D-KBCT will likely play a major role for multiple applications in breast imaging,” Dr. Etta Pisano, principal investigator of the 3D-KBCT study, said in a release.

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