Imagen Technologies wins FDA nod for computer-assisted detection device

Left shows a chest radiograph. Right shows the output of FDA-cleared software, Aorta-CAD on the same chest radiograph. The software is identifying and highlighting aortic calcifications as suggestive of aortic atherosclerosis. [Image courtesy of Imagen Technologies]Imagen Technologies announced today that the FDA cleared its computer-assisted detection (CADe) device, Aorta-CAD.

New York-based Imagen designed Aorta-CAD to assist physicians in detecting findings on chest X-rays. Those findings may suggest the prevalence of aortic atherosclerosis and aortic ectasia.

The cloud-based, software-only medical device uses deep learning to detect and highlight its findings. According to a news release, it makes up part of Imagen’s diagnostics as a service (DaaS) platform. It assists any physician reading chest X-rays, including radiologists and primary care physicians.

Imagen’s fourth FDA clearance could lead to earlier and better detection and treatment …

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