FDA Approves 3D Breast CT

February 5, 2015

The FDA has approved the first cone beam CT for diagnostic imaging of the breast, according to Koning Corporation.

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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