Digital x-ray manufacturer KA Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for Reveal, a portable single-exposure dual-energy digital radiography (DR) detector.
First launched earlier in 2020, Reveal enables dual-energy digital x-ray to be performed at the patient's bedside. Dual-energy imaging confers benefits due to the ability to remove bones from images, which can obscure pathology. Alternatively, users can produce images that remove soft tissue and highlight bone.
The company believes the technology is particularly advantageous in the COVID-19 era, when it can be risky to transport infectious patients to the radiology department. The company points out that current dual-energy digital x-ray systems are stationary.
KA Imaging is planning to conduct clinical trials around the world to show the efficacy of Reveal as a tool to triage COVID-19 patients and perform other imaging tasks in the emergency room and intensive care unit settings; one such trial has already started in Toronto, Canada.
