PARCA eNews – September 22, 2020 – 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 company’s Reveal™ machine enables bone and soft-tissue differentiation without motion artifacts in a single X-ray exposure. In other words, with one shot, the detector simultaneously delivers DR, bone, and tissue images.
By differentiating between the tissue and bone without disruptions of other body parts that move during imaging, such as the heart provides radiologists with unobstructed views of the lungs, which can aid in the visualization of pneumonia, fractures, catheters, and masses with high sensitivity.
In a new clinical trial that began in September in Toronto the company seeks to provide early and reliable detection of pneumonia, including COVID-19. The objective is to determine how effective it is in triaging COVID-19 infection prior to patients experiencing a drop in blood oxygen saturation.
“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,” said Dr. Karim S. Karim, CTO of KA Imaging.
Source: KA Imaging press release
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