New AI Modality Gets FDA Nod for Detecting Aortic Atherosclerosis and Ectasia on Chest X-Rays
One study showed use of the Aorta-CAD cloud-based software led to a 62 percent reduction of missed aortic calcification that suggested aortic atherosclerosis.
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.
Newsletter
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
