C4 Imaging Receives Additional FDA 510(k) Clearance for its Positive-Signal MRI Marker
C4 Imaging received additional FDA 510(k) marketing clearance for its Sirius MRI Marker, a novel positive-signal MRI marker used during the treatment of prostate cancer with brachytherapy.
The additional 510(k) clears Sirius MRI Markers for sterilization with ethylene oxide. Previously only gamma sterilization was available.
The company is assessing plans to supply Sirius for prostate cancer patients outside the U.S.