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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,
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
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Trastuzumab Deruxtecan Receives FDA Approval for HER2-Positive Solid Tumors
April 5th 2024FDA granted accelerated approval to trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.
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