Additional 510(k) clearance granted for prostate MRI Marker
The FDA has granted an additional 510(k) clearance for the Sirius MRI Marker, a novel positive-signal MRI Marker that is used during the treatment of prostate cancer with brachytherapy. This additional 510(k) clears Sirius MRI Markers to be sterilized with ethylene oxide; previously, only gamma sterilization was available, according to manufacturer C4 Imaging LLC. The addition of ethylene oxide as an option increases convenience for customers and allows the benefits of MRI-assisted brachytherapy with Sirius to be made available to more prostate cancer patients, the company says.
For more information, go to www.c4imaging.com/.