Aorta-CAD

by Imagen Technologies  · Based in United States → — Improving the accessibility, accuracy, and immediacy of frontline diagnostic imaging.
Cardiology Internal Medicine Radiology

Regulatory Status Disclosed

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

Coronary Artery Assessment
Aorta-CAD assists physicians in detecting findings on chest X-rays that are suggestive of aortic atherosclerosis and aortic ectasia. In clinical trials, the device showed a 62% relative reduction in misses for aortic calcification suggestive of aortic atherosclerosis and a 35% relative reduction in misses for dilated aorta indicative of aortic ectasia. The presence of thoracic aortic calcification (TAC) is associated with coronary artery disease (CAD), with calcification in the descending aorta and aortic root showing a stronger association. CT-based measures of calcification in the abdominal aorta can predict cardiovascular events.
AHA/ACC Guideline Alignment
The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease provides recommendations for diagnosis, genetic evaluation, medical therapy, and treatment of aortic disease, including guidance on imaging acquisition, measurement, and reporting of aortic dimensions. The guidelines also address surgical intervention thresholds for aortic root and ascending aortic aneurysms.
Physician Tip

Aorta-CAD is a valuable tool for primary care physicians and radiologists to enhance the detection of aortic atherosclerosis and aortic ectasia from chest X-rays. The AI-powered annotations can draw attention to suspicious regions, potentially leading to earlier diagnosis and treatment of chronic aortic conditions. While Aorta-CAD is a helpful aid, it is crucial to remember that it does not replace the physician's role or other diagnostic testing. Consider integrating this tool into existing chest X-ray workflows for improved efficiency and patient outcomes.

Aorta-CAD is a cloud-based, software-only medical device that integrates seamlessly into current chest X-ray workflows. It does not require new Picture Archiving and Communication System (PACS) technology or costly re-training. The device is part of Imagen's Diagnostics as a Service (DaaS) platform. The overlay with annotations can be toggled on or off within the PACS viewer for concurrent review.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentCloud-based software that integrates into existing chest X-ray workflows and Picture Archiving and Communication System (PACS) viewers.
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Radiology

What the Web Says

Aorta-CAD by Imagen Technologies is a computer-assisted detection (CADe) software device that uses deep learning to analyze chest radiographs for suspicious regions of interest (ROIs) related to aortic calcification (suggestive of Aortic Atherosclerosis) and dilated aorta (suggestive of Aortic Ectasia). It is intended as a concurrent reading aid for physicians and does not replace their role or other diagnostic testing. The software has received FDA clearance and is integrated into Imagen's Diagnostics as a Service platform.

Overall: Positive

Strengths

  • Aids physicians in detecting aortic atherosclerosis and aortic ectasia from chest X-rays.
  • Reduces missed aortic calcifications by 62% and missed dilated aortas by 35%.
  • Uses deep learning and computer vision techniques for analysis.
  • Output is available as a concurrent reading aid, allowing physicians to toggle the overlay on or off.
  • Demonstrated improved reader accuracy in detecting aortic calcification and dilated aorta in clinical studies.
  • Cloud-based solution, part of Imagen's Diagnostics as a Service platform.

Limitations

  • Does not replace the role of the physician or other diagnostic testing.
  • Indicated for adults only.
  • Integration into existing hospital systems can be a challenge, requiring seamless embedding into daily practices and potentially incurring additional IT costs.
  • Trust and reliability in AI performance are crucial for physicians, who need confidence that AI tools perform comparably to traditional diagnostics without unintended consequences like false positives.

Based on reviews from: ottawacitizen.com, fda.gov, auntminnie.com, lelezard.com, arci.org, theimagingwire.com, revmedconnect.com, fda.report, innolitics.com, parikhradiology.com, cardio-tomsk.ru, archive.org

Last updated: 2026-10-30

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Press & Coverage

PR Newswire
Imagen Technologies Announces FDA Clearance of Aorta-CAD
Imagen Technologies, Inc. announced the U.S. Food and Drug Administration's 510(k) clearance of the computer-assisted detection (CADe) device Aorta-CAD, designed to assist physicians in detecting findings on chest X-rays suggestive of Aortic Atherosclerosis and Aortic Ectasia. This marks Imagen's fourth FDA clearance and aims to improve patient outcomes by making frontline imaging diagnostics suitable for primary care offices.
2022-12
MPO Magazine
FDA OKs Imagen's Aorta-CAD Software
Imagen Technologies received FDA 510(k) clearance for its Aorta-CAD software, an AI-powered device that helps physicians detect signs of aortic atherosclerosis and aortic ectasia on chest X-rays. The cloud-based software uses deep learning to highlight findings and integrates into existing workflows without requiring new PACS technology or extensive retraining.
2022-12
Medical Device Network
Imagen Technologies' Aorta-CAD device receives FDA 510(k) clearance
Imagen Technologies has secured 510(k) clearance from the US FDA for Aorta-CAD, a cloud-based, software-only medical device that uses deep learning to identify and highlight findings related to aortic atherosclerosis and aortic ectasia on chest X-rays. Clinical trials showed a 62% relative reduction in missed aortic calcification and a 35% relative reduction in missed dilated aortas, with 96% of physicians showing improvement when assisted by the device.
2022-12
MassDevice
Imagen Technologies wins FDA nod for computer-assisted detection device
Imagen Technologies announced that the FDA cleared its Aorta-CAD computer-assisted detection (CADe) device, designed to help physicians detect findings on chest X-rays that may suggest aortic atherosclerosis and aortic ectasia. This cloud-based, software-only medical device uses deep learning and is part of Imagen's diagnostics as a service (DaaS) platform.
2022-12
AuntMinnie.com
Imagen gets FDA nod for Aorta-CAD
Imagen Technologies has received FDA clearance for Aorta-CAD, software that assists physicians in identifying findings on chest X-rays indicative of aortic atherosclerosis and aortic ectasia. The cloud-based software, integrated into its DaaS platform, reportedly reduces missed aortic calcifications by 62% and missed dilated aortas by 35%.
2022-12
Applied Radiology
Imagen Gets FDA Nod for Aorta-CAD
Imagen Technologies, Inc. has received US FDA 510(k) clearance for its Aorta-CAD computer-assisted detection (CADe) device, intended to help physicians detect signs of Aortic Atherosclerosis and Aortic Ectasia on chest X-rays. The cloud-based, AI-powered software is part of Imagen's Diagnostics as a Service (DaaS) platform and aims to enable earlier detection and treatment of these chronic diseases.
2022-12
Diagnostic Imaging
FDA clears Imagen Technologies' Aorta-CAD
The FDA has granted 510(k) clearance to Aorta-CAD from Imagen Technologies, a cloud-based software device that utilizes deep learning to assist in detecting aortic atherosclerosis and aortic ectasia. This device is designed to help physicians identify previously undiagnosed chronic ailments.
2022-12
FDA.gov
510(k) Premarket Notification K213353
The FDA granted 510(k) clearance for Aorta-CAD on September 20, 2022. Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs) using a deep learning algorithm, identifying aortic calcification or dilated aorta. It is intended as a concurrent reading aid for physicians looking for ROIs suggestive of Aortic Atherosclerosis or Aortic Ectasia in adults.
2022-09

Videos

Product demos, reviews, and walkthroughs for Aorta-CAD.

View all on YouTube

Frequently Asked Questions

Aorta-CAD is designed to integrate seamlessly with existing PACS and EMR platforms, often using standard protocols like DICOM. It functions as a concurrent reading aid, providing automated analysis and highlighting findings suggestive of Aortic Atherosclerosis and Aortic Ectasia on chest X-rays within the physician's existing workflow, aiming to enhance efficiency without requiring new PACS technology or costly re-training.
Aorta-CAD has received U.S. Food and Drug Administration (FDA) 510(k) clearance as a computer-assisted detection (CADe) device. While specific details on CE Mark were not found, AI solutions in healthcare generally employ robust encryption, access controls, and de-identification protocols to comply with patient data privacy regulations like HIPAA and GDPR.
Traditional methods for detecting aortic conditions often involve manual interpretation of imaging studies like CT or MRI by expert radiologists and cardiologists, with CT being the gold standard for aortic diameter measurement. Aorta-CAD is intended as a concurrent reading aid to assist physicians in detecting findings on chest X-rays suggestive of Aortic Atherosclerosis and Aortic Ectasia, not to replace the physician or other diagnostic testing. Clinical trials have shown that physicians, when assisted by Aorta-CAD, experienced a 62% relative reduction in misses for aortic calcification and a 35% relative reduction in misses for dilated aorta, with 96% of physicians showing improvement.
The specific pricing model for Aorta-CAD (e.g., subscription, per-study, or capital expenditure) is not explicitly detailed in the provided search results. However, AI solutions in healthcare often offer flexible pricing structures. While direct reimbursement codes for AI-assisted interpretation are still evolving, the system aims to support existing diagnostic codes by enhancing efficiency and accuracy.
Aorta-CAD is indicated for adults only and analyzes chest radiograph studies for suspicious regions. While designed for high accuracy, AI models can have limitations such as performance variations with severe image artifacts, unusual anatomies, or specific rare pathologies not extensively represented in training data. The clinical trial for Aorta-CAD reported a 62% relative reduction in misses for aortic calcification and a 35% relative reduction in misses for dilated aorta.
While the exact frequency of updates for Aorta-CAD is not specified, AI solutions generally undergo regular updates to enhance features, improve model performance, and address identified issues. These updates are typically deployed through secure, validated channels, and the development roadmap often incorporates feedback from clinical users and new research findings to continuously refine capabilities.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-20 | First Added: 2026-04-20
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