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.
10 Things to Know About MagSense®, Part 1: Why the Imaging Market Needs MagSense
October 22, 2026
Bringing molecular specificity to MRI could change the way cancer is diagnosed. We’re proud of the first-of-its-kind technology behind MagSense®, but breakthrough technology alone does