With the 510(k) clearance, practitioners can leverage dual-energy at the bedside for the first time
WATERLOO, Ontario– KA Imaging’s portable dual-energy X-ray detector have received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Reveal™ enables bone and soft-tissue differentiation without motion artifacts in a single X-ray exposure. In other words, with one shot, the detector simultaneously delivers DR, bone, and tissue images.
“We are excited to announce the clearance of Reveal™, after years of dedicated work, and we will strive to apply this technology directly to help patients and medical personnel through these trying times,” said Amol Karnick, President and CEO of KA Imaging.
The different applications for this technology include providing radiologists with unobstructed views of the lungs, which can aid in the visualization of pneumonia, fractures, catheters, and masses with high sensitivity. “The soft tissue and bone images are sharp and free of motion artifacts which increases the diagnostic sensitivity,” said Dr. Karim S. Karim, CTO of KA Imaging.
Reveal is also portable, and can be taken to the bedside of patients, which is critical during these pandemic times.
Whereas fixed dual-energy systems can cost as high as half a million dollars, KA Imaging’s Reveal is highly affordable at less than ¼ of this price.
“Any hospital can now benefit immediately from higher sensitivity X-ray imaging by simply adding dual energy capability to any installed fixed or portable X-ray machines,” said Karnick.
Clinical trials
A new clinical trial began this week in Toronto to seek early and reliable detection of pneumonia (including COVID-19).
“Early triaging is an essential countermeasure to prevent the spread of COVID-19 infection, and we are confident that our technology can make a significant contribution,” said Karim.
Reveal is also being tested on patients with lung cancer at Grand River Hospital in Kitchener, with promising results.
About KA Imaging
A spin-off from the University of Waterloo, KA Imaging is a Canadian company that specializes in developing innovative X-ray imaging technologies and systems, providing solutions to the medical, veterinary and NDT markets. The company has successfully developed a line of innovative x-ray imaging products in the areas of phase contrast micro-computed tomography, ultra-high spatial resolution X-ray detectors and large area digital, dual-energy X-ray material separation detectors.
