• Center on Health Equity & Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

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

Article

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:

http://bit.ly/16gZuEF

Source: University of Rochester Medical Center

Related Videos
Cathy Eng, MD, FACP, FASCO, Vanderbilt-Ingram Cancer Center
Laura Bobolts, PharmD, BCOP, senior vice president of clinical strategy and growth at OncoHealth
Cathy Eng, MD, FACP, FASCO
Jorge García, PharmD, MS, MBA, MHA, FACHE, FACCC
Screenshot of an interview with Shaun McKenzie, MD
Screenshot of an interview with Shaun McKenzie, MD
Screenshot of an interview with Rohan Garje, MD
Susan Escudier, MD, FACP
Sabarish Ayyappan, MD
Related Content
© 2025 MJH Life Sciences
AJMC®
All rights reserved.