Koning Corporation gets FDA nod for breast CT scanner

by Lauren Dubinsky, Senior Reporter | February 05, 2015
CT Women's Health X-Ray
Koning Corporation's Koning
Breast CT system
Courtesy of University of
Rochester Medical Center
Koning Corporation announced today that its Koning Breast CT (KBCT) system and KBCT-guided biopsy bracket received FDA approval. The company claims that it is the first 3-D breast CT scanner on the market that images the whole breast in a single scan without requiring compression.

The procedure is more comfortable than mammography because the breast isn't compressed and less radiation is administered to the patient since only the breast is exposed to the X-rays, according to a 2014 FDA statement.

And although physicians need to learn how to read and interpret the images the machine produces, they are less distorted than mammography images and the KBCT can differentiate between soft tissue and cancer tissue, which makes the process easier.
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During the exam, the patient lies face down on an exam table. Then each breast is suspended through an opening in the table. A cone-beam shaped radiation source under the table, which prevents exposure of the chest and torso, then captures hundreds of 3-D images in approximately 10 seconds.

A biopsy bracket is an optional accessory. It allows for KBCT-guided breast biopsies with equivalent or lower radiation exposure compared to stereotactic-guided biopsies. It also includes an optional collimator that is used to direct the X-ray beam only to the required area.

KBCT is not meant to replace mammography as a screening tool. Instead, says its developer in a statement, it is meant for diagnosing cancer in patients who already have shown symptoms or have suspicious findings after a screening mammogram.

Professor Ruola Ning of the University of Rochester Medical Center and president and founder of Koning Corporation started the development process about a decade ago. He received his first patent for the cone beam CT technology in 1999. The shape allows the entire volume of an organ to be scanned in one rotation

KBCT also has regulatory approval in Europe, Canada and Australia and the company anticipates that it will receive approval in China in 2015.

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