Aorta-CAD
Overview
Aorta-CAD, developed by Imagen Technologies, is an FDA-cleared, cloud-based, software-only medical device leveraging deep learning to assist physicians in detecting findings on chest X-rays suggestive of Aortic Atherosclerosis and Aortic Ectasia. It is designed to be a concurrent reading aid for physicians, including radiologists and Primary Care Physicians (PCPs), by identifying and highlighting suspicious regions of interest (ROIs) with annotations on the X-ray image via an overlay.
The device seamlessly integrates into existing X-ray reading workflows without requiring new Picture Archiving and Communication System (PACS) technology or costly re-training of physicians. Clinical studies have demonstrated its effectiveness, showing a 62% relative reduction in misses for aortic calcification suggestive of Aortic Atherosclerosis and a 35% relative reduction in misses for dilated aorta suggestive of Aortic Ectasia. Overall, 96% of physicians showed improvement when assisted by Aorta-CAD. Aorta-CAD is part of Imagen’s Diagnostics as a Service (DaaS) platform, aiming to improve patient outcomes through earlier and more accurate diagnoses.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Detects and highlights radiographic findings suggestive of Aortic Atherosclerosis and Aortic Ectasia
- Cloud-based, software-only medical device
- Utilizes deep learning algorithms for analysis
- Seamlessly integrates into existing X-ray reading workflows
- Creates annotations via an overlay that can be toggled on/off
- Assists physicians (radiologists and PCPs) in interpreting chest X-rays
- Demonstrated 62% relative reduction in misses for aortic calcification in clinical study
- Demonstrated 35% relative reduction in misses for dilated aorta in clinical study
- Part of Imagen's Diagnostics as a Service (DaaS) platform
- Indicated for adults only
Use Cases
- Early detection of Aortic Atherosclerosis
- Early detection of Aortic Ectasia
- Assisting physicians in interpreting chest X-rays
- Improving diagnostic accuracy and reducing misinterpretation rates
- Enhancing patient treatment plans and care
- Identifying previously undiagnosed chronic ailments
What Physicians Need to Know
Aorta-CAD serves as an assistive tool to enhance the detection of aortic atherosclerosis and ectasia on chest X-rays, particularly for primary care physicians and radiologists. Its deep learning algorithms provide a consistent and repeatable process for reviewing the cardiac silhouette. Physicians should consider follow-up imaging, such as CT or MRI, for patients with positive findings to further characterize the detected conditions. The tool's ability to highlight subtle findings can aid in earlier identification of chronic ailments, potentially improving patient outcomes and guiding treatment plans.
Aorta-CAD is a cloud-based, software-only medical device designed for seamless integration into existing X-ray reading workflows. It does not require new Picture Archiving and Communication System (PACS) technology or costly re-training, making it easily adoptable within current clinical environments.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing — Contact Imagen Technologies directly for pricing information. |
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Aorta-CAD received U.S. FDA 510(k) clearance (K213353) on September 20, 2022, as a computer-assisted detection (CADe) software device for analyzing chest radiographs for findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Internal Medicine, Radiology |
What the Web Says
Aorta-CAD is an FDA-cleared, cloud-based AI software designed to assist physicians in detecting findings on chest X-rays suggestive of Aortic Atherosclerosis and Aortic Ectasia. Clinical studies indicate that the software significantly reduces missed diagnoses for these conditions, with 96% of physicians showing improvement when assisted by Aorta-CAD. It integrates seamlessly into existing X-ray reading workflows without requiring new PACS technology or costly retraining.
Overall: PositiveStrengths
- Significantly reduces missed diagnoses for aortic calcification (62% relative reduction) and dilated aorta (35% relative reduction).
- 96% of physicians showed improvement when using Aorta-CAD.
- Cloud-based and software-only, making it easily accessible.
- Integrates into current chest X-ray workflows without needing new PACS technology or extensive retraining.
- Aids in earlier and better detection and treatment of chronic diseases.
- Helps physicians handle higher caseloads and deliver faster turnaround times, potentially preventing burnout.
Limitations
- No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
- General CAD software can have a steep learning curve and be costly, though Aorta-CAD's specific cost isn't mentioned.
Based on reviews from: Imagen, PRNewswire, Applied Radiology, AuntMinnie, DAIC, accessdata.fda.gov
Last updated: 2026-07-20
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