New AI Modality Gets FDA Nod for Detecting Aortic Atherosclerosis and Ectasia on Chest X-Rays

The Food and Drug Administration (FDA) has granted 510(k) clearance to Aorta-CAD (Imagen Technologies), a cloud-based software device which employs deep learning capabilities to help detect aortic atherosclerosis and aortic ectasia on chest X-rays.

Imagen Technologies said the computer-assisted detection (CAD) device creates annotations that alert physicians to findings on chest X-rays that may be indicative of aortic ectasia or atherosclerosis. A clinical trial of the Aorta-CAD device revealed a 35 percent reduction of missed diagnoses for dilated aorta, a finding that suggests aortic ectasia, and a 62 percent reduction of missed diagnoses for aortic calcification, which can be associated with aortic atherosclerosis, according to Imagen Technologies.

“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,” noted Scott Howell, the chief medical officer for Imagen Technologies.

The company adds that Aorta-CAD, which is available through Imagen Technologies’ diagnostics as a service (DaaS) platform, can reportedly be integrated into existing radiology workflows for X-ray reading without costly training or new PACS technology.