FDA Approval for 3D Breast Imaging System Developed by an Academic Startup

The 3D breast imaging system, developed at the University of Rochester, is currently approved for diagnosing cancer in women who have signs or symptoms of the disease, or who have abnormal findings after a standard screening mammogram.

After more than a decade of development and data-gathering -- including breast scans on nearly 700 women and 79 patents issued -- the FDA has approved a breast-cancer imaging system invented by a University of Rochester Medical Center professor. FDA approval of the breast scanner is the latest in a long line of URMC technologies that have been licensed and marketed, including cancer and pediatric vaccines.

The professor,

Ruola Ning, Ph.D.,

is president and founder of Koning Corporation, a URMC startup company. The FDA’s action allows Koning to begin commercial distribution of its Koning Breast CT (KBCT) system. Koning’s medical device passed the FDA’s most stringent premarket approval process, which requires extensive clinical study.

Link to the complete press release:


Source: University of Rochester Medical Center