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.
[VIDEO] EGM Recording – 13 November 2023
November 14, 2023
https://youtu.be/hThLkmpJPW0 EGM 13 November 2023 Video transcript: Welcome and thanks for joining us. Both those joining virtually and those in person. As the time is