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.
Imagion Initiates Manufacturing of MagSense® Drug for Phase 2 Clinical Study on HER2+ Breast Cancer
February 19, 2025
MELBOURNE – Imagion Biosystems (Company) (ASX : IBX), a company dedicated to improving healthcare outcomes through the early detection of cancer, is pleased to announce