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.”
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Imagion Biosystems Delivers Major Milestone — IND Application Lodged with U.S. FDA for Phase 2 Trial of MagSense® HER2 Imaging Agent
January 31, 2026
Imagion Biosystems Hits Major Milestone, Submits IND Application to U.S. FDA for Phase 2 Trial of MagSense® HER2 Imaging Agent Key Highlights: Imagion Biosystems has