C4 Imaging's 1st FDA win is for MRI marker
C4 Imaging celebrates its 1st U.S. regulatory win with 510(k) clearance for the Sirius MRI marker.
C4 Imaging won clearance from the FDA for its 1st product, the Sirius Positive Signal MRI marker, designed for use following the treatment of prostate cancer with brachytherapy.
The MRI marker is designed to facilitate seed localization within the prostate, utilizing a single post-implant MRI procedure.
Brachytherapy involves implanting around 100 radioactive seeds into the prostate. It has risen in popularity because the treatment is considered more effective and convenient, according to the press release.