Decades of Research Yields FDA-Approved Imaging Technology
A 3D imaging system for diagnosing breast cancer that was invented at the URMC received approval from the U.S. Food and Drug Administration.
Ruola Ning, Ph.D., professor of Radiology, began working on the concept as a graduate student and continued the work after he joined the University in 1989. He is president and founder of Koning Corporation, a URMC spinoff company, which is now able to begin commercial distribution of its Koning Breast CT (KBCT) imaging system. The medical device passed the FDA’s most stringent premarket approval process, which required data from multiple clinical trials involving scans of 682 women, and a final review by 18 independent radiologists.
The KBCT system is not currently approved for use as a screening tool. It is for diagnosing cancer in women with abnormal mammograms or other signs of the disease.
According to the FDA, 3D technology is expected to change the landscape for detecting breast cancer because it allows radiologists to view the entire interior structure of the breast more clearly, with high-resolution images. Mammography is two-dimensional, and tomosynthesis artificially creates 3D images from a 2D scan.
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