FDA approves 3D breast CT scanner

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The U.S. Food and Drug Administration has approved a new breast-cancer imaging system called the Koning Breast CT (KBCT) system.

The system was invented by Ruola Ning, PhD, a professor of imaging sciences and electrical and computer imaging at the University of Rochester Medical Center (URMC) in New York and the president and founder of Koning Corporation.

“This dedicated CT scanner for breast imaging is a big deal for the industry,” said David Waldman, M.D., PhD., chair of Imaging Sciences at URMC, in an announcement. “I think what Dr. Ning has accomplished is very impressive and we need to celebrate the innovation. We cannot underestimate how difficult it is to get FDA approval for new technology.”

The KBCT is not intended to be used for breast cancer screening or to replace mammography, but is instead used to diagnose cancer in women who have signs or symptoms of the disease or who have abnormal findings from a standard mammogram.

It’s the first commercially available, 3D breast CT scanner designed to image the breast in a single scan without having to compress the breast. Consequently, It can acquire hundreds of images in a matter of seconds while providing for improved patient comfort

The system was put through a number of studies beginning in 2006. The final study leading to FDA approval, was led by Etta Pisano, MD, a radiologist at the Medical College of South Carolina. In that study 18 radiologists compared more than 230 KBCT scans to conventional mammography scans. "The results we have seen 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," Said Pisano in a statement.