C4 Imaging Earns 510(k) Clearance for Brachytherapy MRI Marker
The FDA has granted C4 Imaging 510(k) marketing clearance for its Sirius positive-signal magnetic resonance imaging (MRI) marker implant for use in treating prostate cancer.
The device is implanted during the treatment of prostate cancer with brachytherapy and is used to locate the radioactive seeds within the prostate, using a single post-implant MRI procedure.
The implant is used with Isoray’s Cesium Blu (Cesium-131) brachytherapy seeds. Cesium-131 is a radioactive isotope that provides a highly targeted treatment to the patient’s cancer site.