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| A patient being screened using the KBCT system--Courtesy of Koning |
Koning has gained a PMA approval for the first 3-D breast computed tomography (CT) scanner to extensively image the breast without compressing it. The Koning Breast CT (KBCT) system is approved to provide 3-D images of the breast for diagnostic purposes. The regulatory agency has been advocating for the incorporation of 3-D imaging into the breast cancer diagnostic process.
The KBCT system requires less patient discomfort than traditional mammography. It does not require compression of the breast between two pieces of glass. Instead, the patient lies on her stomach and inserts the breast into a cone-shaped space during the procedure.
"This FDA approval represents a major step forward for breast imaging and women's health care," Ruola Ning, Koning's founder and president, said in a statement. "KBCT represents a revolutionary advancement in breast cancer diagnosis."
The system produces hundreds of images of a breast in 10 seconds to produce 3-D representations. The FDA approval also includes a biopsy bracket, an optional accessory to enable breast biopsies of suspicious lesions that are guided by the system, as well as a collimator to limit the x-ray beam to the area of interest. It confines the patient's x-ray exposure specifically to the breast, unlike traditional mammography.
Koning anticipates that its breast CT will become a viable substitute for many traditional applications.
The approval of this system represents a step toward the adoption of 3-D imaging, a top priority for the FDA. In September, the FDA issued a statement advocating for innovation in 3-D imaging technology as improving physician's ability to detect tumors and diagnose cancers. It highlighted the work of the FDA's Division of Imaging, Diagnostics, and Software Reliability, which is led by Division Director Kyle Myers.
"They are studying how clinicians receive visual information and analyze it to diagnose a disease. At the center of their research are breast cancer screening devices, which are making the leap from traditional two-dimensional (2-D) screening such as mammography to 3-D breast tomosynthesis, 3-D ultrasound and breast computerized tomography (CT). This technology is very exploratory and years away from becoming standard in your doctor's office," the agency said in that statement.
The FDA has already approved at least two 3-D CT scanners: the Selenia Dimensions 3-D System and the GE Healthcare ($GE) SenoClair, which combines 2-D and 3-D images.
"Clinical studies have shown that 3-D breast tomosynthesis can increase the cancer detection rate, reduce the number of women sent for biopsy who don't have cancer, or achieve some balance of these two goals of this new screening technology," Myers said in the statement.
Describing a system like the newly approved Koning one, she added, "These images will be very different from 2-D mammograms. They're truly 3-D images of the 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."
- here is the Koning release