KA Imaging’s Portable X-Ray Detector Receives FDA OK

The FDA has handed KA Imaging 510(k) clearance for its portable, dual-energy X-ray detector, a device that provides unobstructed imaging of the lungs.

The small X-ray device, named Reveal, can be used by a patient’s bedside to simultaneously provide digital radiography, bone and tissue images.

The company said the technology can help in the visualization of pneumonia, fractures, catheters and high-sensitivity masses. It is currently being evaluated in a clinical trial in Canada for early detection of pneumonia, including COVID-19-associated pneumonia.