ControlRad® Announces FDA Clearance for ControlRad Select
ATLANTA, March 4, 2021 /PRNewswire/ -- ControlRad, Inc., a privately held medical technology company focused on dramatically reducing unnecessary radiation exposure during fluoroscopically guided procedures, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select. The technology utilizes proprietary semi-transparent filters, a user-interface tablet, and image processing algorithms, which are retrofitted onto customers' existing Siemens Artis zee interventional imaging systems.
In preparation for the commercialization efforts, ControlRad has entered into an exclusive agreement with Boston Scientific Corporation to sell the ControlRad Select technology.
"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%1 without compromising image quality," stated Guillaume Bailliard, CEO of ControlRad.
"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," stated Simon Dixon, MD, Chief of Cardiology at Beaumont Hospital, Royal Oak, Michigan. "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."
For additional information about the product or to contact a sales representative, visit www.bostonscientific.com/controlrad. For media inquiries, email [email protected].
About ControlRad
ControlRad is a privately held medical technology company developing innovative products that dramatically reduce the radiation exposure from fluoroscopically guided procedures (FGP) for patients and healthcare professionals. ControlRad's products are designed to improve safety without compromising image quality or workflow. They include an integrated set of proprietary components, which optimize the X-ray beam to deliver optimal image quality in the clinically relevant region, while maintaining appropriate resolution in the periphery. ControlRad is headquartered in Atlanta, Georgia and has engineering development facilities in Kfar Saba, Israel. For more information, visit www.controlrad.com.
1 FDA 510(k) K202431
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