KA Imaging said that Reveal, its portable dual-energy X-ray detector has been granted 510(k) clearance from the US Food and Drug Administration (FDA).
The Canadian X-ray detector manufacturer said that Reveal enables differentiation of bones and soft-tissues without motion artifacts in a single X-ray exposure, which means with a single shot, the detector simultaneously generates DR, bone, and tissue images.
Amol Karnick – President and CEO of KA Imaging said: “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.”
According to KA Imaging, the various applications for the Reveal technology include giving radiologists with unhindered views of the lungs, which can help in visualizing pneumonia, catheters, fractures, and masses with high sensitivity.
Dr. Karim S. Karim – CTO of KA Imaging said: “The soft tissue and bone images are sharp and free of motion artifacts which increases the diagnostic sensitivity.”
KA Imaging added further that the Reveal X-ray detector is also portable, making it possible to be taken to the bedside of patients, which is very important during the prevailing Covid-19 pandemic.
The Canadian company said that a new clinical trial for its X-ray detector has been launched in Toronto to seek early and reliable detection of pneumonia, including COVID-19. Furthermore, Reveal is also being evaluated at the Grand River Hospital in Kitcheneron in patients having lung cancer, where it is said to have delevered promising results.