May 22, 2019
ATLANTA–(BUSINESS WIRE)–ControlRad, Inc., a privately held medical technology company focused on dramatically reducing unnecessary radiation exposure during fluoroscopically guided procedures, today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its ControlRad Trace and the company has initiated its commercial launch. The ControlRad Trace is the only technology that can be integrated into existing mobile C-arms to reduce radiation in any fluoroscopic imaging procedure.
“Radiologists and our teams have grave concerns about the long-term effects from radiation exposure,” said John A. Carrino, M.D., M.P.H., vice chairman of Radiology, Hospital for Special Surgery. “I am excited that new technology for mobile C-arms is now available because it has the potential to drastically improve our radiation safety while maintaining image quality so we can continue to effectively diagnose and treat our patients. I believe these new products should become the standard of care for fluoroscopic procedures.”
Fluoroscopically guided procedures (FGP) with C-arms have allowed for major advances in treating countless diseases, however they expose patients and medical staff to ionizing radiation, which may increase a person’s lifetime risk of developing cancer.2 For example, an interventional fluoroscopy procedure is roughly equivalent to the adult effective dose of between 250-3,500 chest X-rays.3
“Radiation from C-arm procedures may increase the risk of brain cancer, cataracts, strokes and atherosclerosis,” says Guillaume Bailliard, ControlRad chief executive officer. “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.”
With its proprietary semi-transparent filter, tablet and image processing technology, the ControlRad Trace solution can be retrofitted on existing C-arms, reducing the barrier to adopting the technology in order to reduce unnecessary radiation up to 89%,1 without compromising image quality in the region of interest and overall workflow. The medical staff draws a region of interest (ROI) on a ControlRad tablet, which in real-time optimizes image quality in the ROI while reducing unnecessary radiation in the periphery.
“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,” says Chris Fair, ControlRad executive vice president and president, Mobile C-arm division. “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.”
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 Data on file
2 https://www.fda.gov/radiation-emitting-products/initiative-reduce-unnecessary-radiation-exposure-medical-imaging/white-paper-initiative-reduce-unnecessary-radiation-exposure-medical-imaging, p. 1
3 Ibid, p. 3