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.
The Unanswered Question in Prostate Cancer Diagnosis
September 24, 2026
Separating lethal disease from indolent disease remains the persistent difficulty, and molecular MRI may offer a way to see the difference. Prostate cancer is the