FDA Approves Breast Imager That Does Not Compress Tissue
The US Food and Drug Administration (FDA) has approved the first CT system that provides three-dimensional (3D) images for diagnostic breast imaging.
The Koning Breast CT (KBCT), which does not require compression of the breast, “should be read along with standard 2-view mammography,” according to the FDA premarket approval application letter issued January 14.
“This FDA approval represents a major step forward for breast imaging and women’s healthcare,” said Ruola Ning, PhD, president and founder of Koning, in a press statement. Dr Ning is the inventor of “cone beam” breast CT technology, which is used in the Koning device.
The KBCT is intended for diagnostic breast imaging in patients who have signs or symptoms of disease or who have abnormal imaging findings. It is not intended for breast cancer screening in an asymptomatic population.
The ability of the device to image the breast without compression “eliminates a major source of patient discomfort,” according to a Medscape Oncology 2012 report on the 3D technology.
With the KBCT, the patient lies face down on a table that is located above the KBCT hardware. The table has an opening to allow one breast to hang through it, according to FDA materials.
In less than 10 seconds, the KBCT hardware rotates around the breast and acquires data that is used by the software to reconstruct cross-sectional 3D images of the entire breast. Throughout the process, the breast in never compressed.
This is not the first 3D CT scanner of the breast.
The FDA has already approved at least two others — the Selenia Dimensions 3D System, which is approved as a diagnostic and screening tool, and the GE Healthcare SenoClaire, which combines 2D and 3D images — according to a news report.