FDA clears ControlRad fluoroscopy radiation reduction software

ControlRad has announced the launch of ControlRad Trace, technology to reduce radiation in any fluoroscopic procedure in conjunction with 510(k) clearance by the U.S. Food and Drug Administration. The software is used with mobile C-arms.

The Atlanta, GA-headquartered company said that ControlRad Trace’s proprietary semi-transparent filter, tablet, and image processing technology enables its retrofitting on existing C-arms without compromising image quality in the region of interest and overall workflow. After a region of interest is drawn on a ControlRad tablet, the software optimizes image quality in real time in the region of interest while reducing unnecessary radiation in the periphery.

When using ControlRad Trace, unnecessary radiation can be reduced up to 89%, according to ControlRad. Over 17 million fluoroscopic procedures are performed annually in the United States.

The company is in the process of initiating commercialization of ControlRad Trace, which is expected to be available for sale in the United States later this year.