FDA clears ControlRad tech for reducing cath lab radiation exposure by 85%
The FDA has cleared ControlRad’s set of add-on X-ray filters and image-processing algorithms, which together can help retrofit installed systems to reduce unnecessary radiation exposure without sacrificing scan quality.
Designed for fluoroscopy-guided procedures, the ControlRad Select package interfaces with Siemens’ Artis zee line of fixed, C-arm scanners. In addition, the company has signed an exclusive distribution agreement with Boston Scientific to commercialize the system.
"With the FDA clearance and the reach of the global medical device sales team, every cath, EP, and IR lab in the country that has a Siemens Artis zee will now have the opportunity to reduce their radiation dose by 85% without compromising image quality," ControlRad CEO Guillaume Bailliard said.
A separate product, ControlRad Trace, received an FDA clearance last September for use with GE Healthcare’s OEC 9900 mobile C-arm systems.
Both use dynamic, semi-transparent filters and a tableside tablet to optimize the X-ray beam, reducing peripheral exposure to the patient and healthcare staff by at least 50% and as much as 85%.
According to ControlRad and Boston Scientific, career-long radiation exposure to clinicians can result in higher lifetime risks of cataracts, stroke, atherosclerosis and brain cancer.