Ka Imaging Secures FDA Clearance for COVID-19 Detecting Dual-Energy X-ray

The U.S. Food & Drug Administration (FDA) awarded 510(k) clearance to Ka Imaging, Inc., Monday for Reveal, its portable, dual-energy X-ray detector that, company officials, said can be used to slow the spread of COVID-19.

The detector differentiates itself by providing regular digital X-rays of bone and tissue in a single exposure, differentiating between the two without disruptions of other body parts that move during imaging, such as the heart. It is also designed for early detection of pneumonia, including COVID-19.

“What our dual energy X-ray imaging allows you to do is to produce in a single exposure of the lungs and ribs and look at them individually,” said Amol Karnick, Ka Imaging president and chief executive officer. “A good example is lung cancer where you may have a lesion or tumor hiding behind the rib cage. You remove the ribcage image and now you can see the lesion.”

In addition, Karnick said, Reveal also reduces radiation exposure and eliminates the quarter-to-half-second delay between separate exposures captured with existing dual energy X-ray imaging, eliminating potential image distortion.

Ka Imaging is testing the efficacy of its system in a 600-participant clinical trial at Toronto’s University of Health Network. The team is looking to determine how well it images lung disease, including pneumonia, as well as how effective it is in triaging COVID-19 infection prior to patients experiencing a drop in blood oxygen saturation. The trial will also compare thoracic tomograms to CT scans for early COVID-19 detection, and that data will be used to build an artificial intelligence model for automated and nearly instantaneous image interpretation, company officials said.