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FDA gives thumbs-up to launch of ControlRad Trace

by John R. Fischer, Senior Reporter | May 28, 2019
ControlRAD Trace is the only solution,
according to ControlRad, that can
integrate with mobile c-arms
The FDA has given ControlRad the thumbs-up sign for the launch of its radiation reduction technology, ControlRad Trace.

Able to decrease dose in any fluoroscopic imaging procedure, the company claims the solution is the only one capable of integrating with existing mobile C-arms.

“New C-arm technology does not provide this level of radiation reduction combined with this high level of image quality. With ControlRad Trace, it is easier for hospitals to integrate without making any changes to the hospital and clinician workflow, and [this] results in dose reduction for all involved,” Chris Fair, executive vice president and president of the mobile C-arm division of ControlRad, told HCB News. “Hospitals or ASCs can retrofit their existing qualified mobile C-arms, which are used by a variety of specialists who perform fluoroscopically guided procedures.”

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More than 17 million fluoroscopic operations occur in the U.S. annually. While necessary for treating countless diseases, such procedures expose 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.

Equipped with proprietary semi-transparent filter, tablet and image processing technology, the ControlRad Trace solution reduces the barrier to adopting the technology when retrofitted to existing C-arms. This allows it to reduce unnecessary radiation by up to 89 percent, without compromising image quality in the region of interest and overall workflow.

Clinicians draw a region of interest (ROI) on a ControlRad tablet, which, in real-time, optimizes image quality in the ROI and reduces unnecessary radiation in the periphery.

“Another distinguishing advantage is that ControlRad Trace can be used in any fluoroscopically guided procedure, be it spine, trauma, vascular or pain management. Nursing staffs and support personnel combined with the physicians will benefit the most from this solution.”

The solution is available for sale.

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