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 for chronic diseases, the company said. Aorta-CAD leaves physicians better-equipped to diagnose and begin treating the conditions earlier. Additionally, it helps practices identify previously undiagnosed ailments, improving the patient’s quality of life and reducing the cost of care.
Aorta-CAD identifies findings on the chest X-ray image and creates annotations drawing attention to those findings. This overlay can toggle on and off when not in use by a physician. It seamlessly integrates into existing X-ray reading workflows without the need for new PACS technology or costly re-training of physicians.
“Imagen is on a mission to help primary care physicians deliver faster, better diagnoses and care plans,” said Imagen CEO Alex Dresner. “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.”