FDA clears cloud-based AI for assistance in detecting aortic atherosclerosis, ectasia
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Imagen Technologies, Inc. announced the FDA issued 510(k) clearance of the company’s cloud-based, deep learning software to assist in the detection of aortic atherosclerosis and aortic ectasia on chest X-rays.
The software (Aorta-CAD) seamlessly integrates into existing workflows without the need for new picture archiving and communication system technology or retraining, according to a company press release. It is designed to assist any physician who reads chest X-rays, including radiologists and primary care physicians.
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The deep learning software identifies findings on the chest X-ray image; annotates findings via an overlay; and can be toggled off when not being used, according to the release.
Use of the deep learning software was associated with a reduction in misses for aortic calcification, suggestive of aortic atherosclerosis, and a reduction in misses for dilated aorta, suggestive of aortic ectasia, according to the release.
"Aorta-CAD assists the physician to have a consistent and repeatable process to look into the cardiac silhouette providing additional information to enhance the patient's treatment plans and care," Scott Howell, MD, Chief Medical Officer for Imagen, said in the release.
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