FDA Approves 3D-Koning Breast CT

Koning Corporation, a leading developer of advanced medical imaging systems announced today that the FDA has approved their Koning Breast CT (KBCT) system and KBCT-guided biopsy bracket. This approval signals that KBCT has undergone and successfully completed all aspects of FDA’s rigorous Pre- Market Approval (PMA) process for medical devices to include extensive clinical study. KBCT is intended to provide three-dimensional (3D) images for diagnostic imaging of the breast.

“This FDA approval represents a major step forward for breast imaging and women’s health care,” said Ruola Ning, PhD, Koning’s President and Founder, a pioneer and leading expert in Cone Beam CT Technology and sole inventor of cone beam breast CT technology. “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.”

KBCT is the first ever commercially available, 3D breast CT scanner designed specifically to image the entire breast with a single scan without compression of the breast tissue. The system acquires hundreds of images in ten seconds producing ‘true’ 3D images allowing a fast procedure with excellent patient comfort.  Optional accessories for  KBCT include a biopsy bracket to enable KBCT-guided breast biopsies of suspicious lesions, and a collimator which is used to limit the x-ray beam to the area of interest.  The biopsy bracket provides 3D targeting at comparable or lower radiation exposure compared to stereotactic guided biopsy.

In a September 2014 FDA Consumer Health Information “3D Technologies Poised to Change How Doctors Diagnose Cancer” FDA reported that thanks to the regulatory work being done by a team of scientists at FDA that soon, three-dimensional (3D) images in actual 3D might help your doctor find hidden tumors and better diagnose cancers. The article indicated that:  for patients, the (breast CT) procedure is more comfortable than regular mammography because the breast isn’t compressed. Also, there’s less radiation exposure than during a CT exam of the entire chest because only the breast is exposed to X-rays. The (breast CT) images have less distortion than mammography, and the system is optimized to differentiate between the breast’s soft tissue and cancer tissue.  These images will be very different from 2D mammograms. They’re truly 3D images of the entire breast from any orientation. You can scroll through the slices (up and down, left and right) and get a unique view of the breast like never before.  It gives doctors tremendous freedom in how they look at the interior of the breast and evaluate its structures.  It’s almost like seeing the anatomy itself.

Over 680 patient scans on KBCT were conducted at Elizabeth Wende Breast Care (Rochester, New York) and the University of Rochester Medical Center (URMC-Rochester, New York), with additional collaboration at the University of Massachusetts Medical Center (Wooster, Massachusetts) which culminated in a large reader study conducted at the Medical College of South Carolina (MUSC) with Dr. Etta Pisano, a world renowned expert in Breast Imaging, serving as the Principal Investigator. “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,” Dr. Pisano said.

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