• 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
Wanmei Ou, PhD, vice president of product, data analytics, and AI at Ontada
Glenn Balasky, executive director of the Rocky Mountain Cancer Center.
Corey McEwen, PharmD, MS
dr linda bosserman
dr andrew leitner
Glenn Balasky during a video interview
dr joseph alvarnas
dr joseph alvarnas
Related Content
© 2024 MJH Life Sciences
AJMC®
All rights reserved.