ControlRad, a privately held medical technology company, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ControlRad Trace technology, which helps reduce radiation in any fluoroscopic imaging procedure.
ControlRad has also announced the commercial launch of the device.
Fluoroscopically guided procedures (FGP) with C-arms have facilitated major advances in treating many diseases. However, the procedure involves exposure of patients and medical staff to ionizing radiation, which may increase the individual’s risk of developing cancer.
ControlRad, which works on reducing unnecessary radiation exposure during fluoroscopically guided procedures, said that the ControlRad Trace is the only technology that can be integrated into existing mobile C-arms to reduce radiation in fluoroscopic imaging procedures.
ControlRad chief executive officer Guillaume Bailliard said: “Radiation from C-arm procedures may increase the risk of brain cancer, cataracts, strokes and atherosclerosis. It’s our mission to dramatically reduce these life-altering radiation health risks to medical personnel and patients.
“This FDA clearance for ControlRad Trace allows us to provide our valuable radiation reduction technology to all mobile C-arm users looking to provide a safer environment without compromising patient care.”
The Trace solution features a semi-transparent filter, tablet and image processing technology and is capable of being retrofitted on existing C-arms.
The device reduces the barrier to adopting the technology and reduces unnecessary radiation up to 89%, without compromising image quality in the region of interest and overall workflow.
The ControlRad tablet is capable of optimising the image quality in the region of interest in real-time, while reducing unnecessary radiation in the periphery.
ControlRad executive vice-president and Mobile C-arm division president Chris Fair said: “With over 17 million fluoroscopic procedures in the U.S. every year, the ControlRad Trace is the only system available that can impact all of them.
“Regardless if it is a pain management treatment, an orthopedic trauma case or even a minimally invasive spine procedure, our technology will reduce radiation exposure and protect those who are saving the lives of others.”