KA Imaging (Waterloo, Ont.) announced today that the FDA has granted 510(k) clearance to its portable, dual-energy X-ray detector.
The Reveal X-ray detector was designed to enable bone and soft-tissue differentiation without motion artifacts in a single X-ray exposure. In other words, with one shot, the detector simultaneously delivers digital radiography, bone, and tissue images.
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. Reveal is also portable, and can be taken to the bedsides of patients.
“The soft tissue and bone images are sharp and free of motion artifacts which increases the diagnostic sensitivity,” said KA Imaging CTO Dr. Karim S. Karim in a news release.
Reveal is being studied in a clinical trial that began this week in Toronto to seek early and reliable detection of pneumonia, including COVID-19. It is also being tested on patients with lung cancer at Grand River Hospital in Kitchener, with promising results, according to the company, a spin-off from the University of Waterloo.
“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,” Karim said.