“Cone Beam Breast CT: Concept and early development to commercialization with regulatory approval”

Abstract: High resolution, isotropic, low dose cone beam breast CT with clinically acceptable image quality has been a research goal for many years. The Cone Beam CT Imaging Lab at URMC has spent over 10 years doing basic research on this project. This research included theoretical modeling, phantom imaging and analysis as well as animal and breast specimen studies. This was primarily done under National Institutes of Health (NIH) awarded-grant funding. In 2002, Koning Corporation was formed as a spin-off company from University of Rochester to commercialize this research. Koning produced the detailed mechanical and controls design for the cone beam breast CT clinical prototype that was built under NIH funding by URMC. The first patient studies on this system were started in 2006. Learning from this clinical prototype, Koning produced the first commercial-grade cone beam breast CT using NIH-awarded Small Business Innovative (SBIR) grant funding. Both systems have the same technical performance (imaging chain, gantry, reconstruction technique and image quality specifications. Mechanical, electrical, programmable and radiation safety testing needed to meet national and international standards. Patient studies on this commercial grade Koning Breast CT (KBCT) system began in 2008. To date, over 600 patient studies have been completed on these 2 systems. A multi-reader multi-case (MRMC) study (18 readers, 236 cases) was performed under FDA requirements using this data pool. Koning has worked closely with the FDA and international regulatory authorities since 2006. In 2010, Koning received ISO13485 certification for its compliant Quality Assurance system, which is a requirement for CE Mark to sell KBCT in the European Union (received in 2012). In 2014, Koning received clearance from both Canada and Australia fro KBCT. Currently, Koning is in the final process for PreMarket Approval (PMA) from the FDA for KBCT.

David Conover, M.S. is the Director of Research and Development at the Koning Corporation. David Conover has twenty five years experience in radiology engineering and radiographic imaging research. He is a licensed medical physicist and senior associate in the Department of Imaging Sciences at the University of Rochester Medical Center.