by John R. Fischer
, Senior Reporter | September 21, 2020
The FDA has approved the integration of ControlRad Trace on OEC 9900 mobile C-arms
The FDA has given ControlRad the green light to integrate its radiation reduction technology with OEC 9900 Mobile C-arms.
Known as ControlRad Trace, the solution is designed to reduce unnecessary radiation exposure during fluoroscopically guided procedures without compromising image quality. ControlRad claims it is the only technology that can be integrated with existing mobile C-arms.
"This additional FDA clearance allows us to offer the critically-important protection of our radiation reduction technology to even more patients and staff in need of mobile C-arm related procedures," said Chris Fair, EVP and president of ControlRad, in a statement.
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While necessary for treating countless diseases, fluoroscopy exposes patients and medical staff to high amounts of ionizing radiation. An interventional fluoroscopy exam, for instance, is roughly equivalent to the adult effective dose of between 250-3,500 chest X-rays. As a result, a person’s lifetime risk of developing cancer may increase.
ControlRad Trace can be retrofitted onto existing mobile C-arms, and comes with a proprietary semi-transparent filter, tablet and image processing technology. Users draw a region of interest on the tablet, which in real-time optimizes image quality in the drawn area while reducing unnecessary radiation in the periphery.
The technology earned FDA clearance
in May 2019 as a product, with the company saying that it could reduce radiation by up to 89% and be traced in any fluoroscopically guided procedure, whether it be spine, trauma, vascular or pain management.
In addition to its new FDA clearance, ControlRad has also closed a Series C financing round led by current investor Questa Capital.
"We are extremely appreciative of the additional investment from Questa and also pleased to welcome new investor Windham Ventures to our investor group,” said Guillaume Bailliard, CEO of ControlRad, in a statement. “We are excited to further build our commercial reach to advance our efforts to help save patients and clinical staff from the harmful effects of excessive radiation.”
ControlRad did not respond for comment.