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FDA approves 3-D breast imaging system
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The FDA has approved the Koning Breast CT, or KBCT, system and KBCT-guided biopsy bracket, the manufacturer announced today.
KBCT (Koning Corp.) is the first commercial 3-D breast CT scanner designed to image the entire breast in a single scan without compressing the breast tissue.
“This FDA approval represents a major step forward for breast imaging and women’s health care,” Ruola Ning, PhD, Koning’s president and founder, said in a press release. “KBCT represents a revolutionary advancement in breast cancer diagnosis. Breast cancer is a growing worldwide women’s health issue impacting hundreds of thousands of women. We are very proud to now be able to offer our technology to benefit women here in the United States.”
The system takes hundreds of images in 10 seconds to produce “true” 3-D images for a fast and comfortable patient experience, according to a press release.
The KBCT system offers optional accessories, including a biopsy bracket to enable KBCT-guided breast biopsies of suspicious lesions and a collimator designed to limit the X-ray beam to the area of interest.
The FDA approval was based on results of more than 680 patient scans on KBCT at Elizabeth Wende Breast Care at Rochester University and the University of Rochester Medical Center in collaboration with the University Of Massachusetts Medical Center. This research led to a large reader study conducted at the Medical College of South Carolina.
“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,” Etta Pisano, MD, principal investigator of the KBCT study at the Medical College of South Carolina, said in a press release.