FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears ControlRad’s C-Arm Radiation Reducer Solution

May 23, 2019
A A

The FDA granted ControlRad 510(k) clearance for its ControlRad Trace technology that is integrated into mobile C-arms to reduce radiation during fluoroscopic imaging procedures.

Trace is designed to reduce the ionizing radiation patients and radiologists are exposed to during procedures, which can increase their lifetime risk of cancer. Radiation produced during C-arm procedures can also increase a patient’s risk of cataracts, atherosclerosis and strokes.

The company says ControlRad Trace reduces radiation up to 89 percent without compromising image quality or workflow.

View today's stories