FDA Clears ControlRad Select Technology for Reducing Radiation Exposure

March 4, 2021—ControlRad, Inc., which is focused on technology to reduce unnecessary radiation exposure during fluoroscopically guided procedures, announced FDA 510(k) clearance to market ControlRad Select.

According to the company, ControlRad Select utilizes semitransparent filters, a user interface tablet, and image processing algorithms that are retrofitted onto customers’ existing Artis Zee interventional imaging systems (Siemens Healthineers).

In preparation for the commercialization efforts, ControlRad has entered into an exclusive agreement with Boston Scientific Corporation to sell the ControlRad Select technology, stated the company.

“The health risks to the medical staff due to lifetime radiation exposure in cath labs have been well documented, including increased incidence of cataracts, atherosclerosis, and even left-brain tumors,” commented Simon Dixon, MD, in the company’s press release.

Dr. Dixon, who is Chief of Cardiology at Beaumont Hospital in Royal Oak, Michigan, continued, “We recently completed a clinical trial designed to evaluate how this novel technology might reduce radiation exposure in the cath lab. I have long been passionate about finding innovative ways to improve safety for my colleagues in the lab while they are performing lifesaving procedures for our patients.”