FDA OKs Imagen’s Aorta-CAD Software

Imagen Technologies has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its computer-assisted detection (CADe) device, Aorta-CAD.
 
The new device assists physicians with detecting chest X-ray findings suggestive of aortic atherosclerosis and aortic ectasia. The cloud-based software uses deep learning to spot and highlight findings to help radiologists and primary care physicians read chest X-rays for the conditions.
 
Aorta-CAD can help identify the previously undiagnosed ailments. The software creates annotations to draw attention to findings via an overlay, which can be toggled off when not being used. It integrates into existing chest X-ray workflows without a need for new PACS tech or costly re-training.
 
“Imagen is on a mission to help Primary Care Physicians deliver faster, better diagnoses and care plans. By expanding our diagnostics as a service platform with Aorta-CAD, we expect to help PCPs significantly improve the quality of care and clinical outcomes for their patients with undiagnosed Aortic Atherosclerosis and Aortic Ectasia,” Alex Dresner, CEO at Imagen Technologies told the press. 
 
Aorta-CAD’s clinical trial showed 62% relative reduction in misses for aortic calcification suggestive of aortic atherosclerosis. It also showed 35% relative reduction in misses for dilated aorta pointing to ectasia, and 96% of physicians demonstrated improvement when assisted by the device.
 
“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,” said Scott Howell, Imagen’s chief medical officer.