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.
Chairman’s Address to Shareholders and Q&A Session at 2023 Annual General Meeting
May 25, 2023
Imagion Biosystems’ Chairman’s address to shareholders at the 2023 Annual General Meeting. PDF of the 2023 AGM Presentation Deck Watch the AGM 2023 Q&A Session