Imagion Biosystems has filed a Pre-Submission with the U.S. Food and Drug Administration (FDA), the first step is gaining approval to commence its first-in-human study. The communication with the FDA’s Center for Devices and Radiological Health (CDRH) follows from the recent notification that the Company’s MagSense System and Test for staging HER2 breast cancer have been designated as a “Breakthrough Device.”
Read the announcement.
Phase 2 HER2 Clinical Trial Manufacturing Commenced, WSU Imaging Optimisation Program Underway
September 9, 2025
Highlights Dr Nina Webster appointed as IBX Non-Executive Director, bringing significant clinical development expertise and corporate experienceto the IBX Board ahead of HER2 Breast cancer