FDA Clears ControlRad's Trace Radiation-Reduction Technology
May 22, 2019—ControlRad, Inc. announced FDA 510(k) clearance and the commercial launch for its ControlRad Trace, which can be integrated into existing mobile C-arms to reduce radiation in any fluoroscopic image-guided procedure.
ControlRad's Trace is composed is of semitransparent filter, tablet, and image processing technology. The device can be retrofitted on existing C-arms to reduce unnecessary radiation up to 89%, without compromising image quality in the region of interest and overall workflow. The medical staff draws a region of interest on a ControlRad tablet, which in real-time optimizes image quality in the region of interest while reducing unnecessary radiation in the periphery.
John A. Carrino, MD, commented in the company's announcement, “Radiologists and our teams have grave concerns about the long-term effects from radiation exposure. I am excited that new technology for mobile C-arms is now available because it has the potential to drastically improve our radiation safety while maintaining image quality so we can continue to effectively diagnose and treat our patients. I believe these new products should become the standard of care for fluoroscopic procedures.” Dr. Carrino is Vice Chairman of Radiology at the Hospital for Special Surgery in New York, New York.