The US Food and Drug Administration (FDA) has granted approval for US-based developer of advanced medical imaging systems Koning's Breast CT (KBCT) system and KBCT-guided biopsy bracket.
The approval signals that the system has undergone and completed all aspects of FDA's premarket approval (PMA) process for medical devices, which will include an extensive clinical study.
Koning developed KBCT to offer three-dimensional (3D) images for diagnostic imaging of the breast.
Koning president Dr Ruola Ning is an expert in cone beam CT technology and sole inventor of cone beam breast CT technology.
Dr Ning said: "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 US."
The company designed the 3D breast CT scanner to image the entire breast with a single scan without compression of the breast tissue.
KBCT holds the capacity to acquire hundreds of images in ten seconds, while its biopsy bracket provides 3D targeting at comparable or lower radiation exposure, compared to a stereotactic guided biopsy.
The biopsy bracket enables KBCT-guided breast biopsies of suspicious lesions and a collimator, which is used to limit the x-ray beam to the area of interest.
More than 680 patient scans on KBCT were conducted at Elizabeth Wende Breast Care and the University of Rochester Medical Center, with additional collaboration at the University of Massachusetts Medical Center.
This culminated in a large reader study conducted at the Medical College of South Carolina (MUSC) with Dr Etta Pisano, an expert in breast imaging, serving as the principal investigator.
Dr Pisano said: "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."
The company received CE Mark approval for KBCT, and it is available for sale in the European Union, Canada and Australia.
Development of KBCT was supported in part by a grant from National Institutes of Health (NIH), SBIR Bridge Grant and Government Grant.