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.
Quarterly Activity Report – Quarter ending 31 December 2023
January 31, 2024
Highlights: Announced positive results from IBI10103 Phase I Study demonstrating safety and clinical feasibility of molecular MRI with MagSense® HER2 Imaging Agent Presented new animal