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 Appoints New Non-Executive Director, Brett Mitchell
MELBOURNE – Imagion Biosystems (ASX:IBX), a company dedicated to improving healthcare through the early detection of cancer, today announced the appointment of Mr Brett Mitchell