Image-guided technology developer C4 Imaging announced that the U.S. Food and Drug Administration (FDA) has granted an additional 510(k) clearance for its Sirius MRI marker.
The new clearance approves the use of ethylene oxide for sterilizing the MRI markers, which are used to evaluate placement of radioactive seeds during MRI-assisted brachytherapy treatment for prostate cancer. Previously, the markers required gamma sterilization, according to the vendor. The new option will add convenience for customers and enables Sirius to be available for more prostate cancer patients, C4 said. The company is also now considering plans to supply Sirius for prostate cancer patients outside of the U.S.
