C4 Imaging, a US-based medical device company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Sirius MRI marker.
Sirius is a positive-signal MRI marker that will be used following treatment of prostate cancer with brachytherapy to facilitate seed localization within the prostate, utilizing a single post-implant magnetic resonance (MR) imaging procedure.
C4 Imaging founder and chairman Dr Steven J Frank noted a positive-signal MRI marker can enhance seed detection, this represents a significant advancement for prostate brachytherapy.
"If seeds can be readily localized with MRI, it would lead to more effective treatment and better patient outcomes," Dr Frank added.
C4 Imaging president and CEO Andrew Bright noted 510(k) clearance for Sirius is a major milestone for the company.
"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 US 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," Bright added.
Sirius is C4 Imaging’s first commercially available positive-signal MRI marker.