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.
“510(k) clearance for Sirius is a major milestone for us," president and CEO Andrew Bright said in prepared remarks. "The encapsulation of a contrast agent within a permanently implantable device allows positive MRI seed localization after brachytherapy to be offered to more than 200,000 men diagnosed with prostate cancer in the U.S. each year. With our 510(k) now cleared, we’re actively pursuing options for supplying Sirius to physicians treating prostate cancer in the U.S., as well as seeking regulatory clearance in Canada and Europe."