Vascular Assist Occlusion Triage (VAOT)

by GuideAI Health  · Based in United States → — AI-powered triage directly into the radiology workflow, helping clinicians identify vascular disease sooner so patients can be directed to the right care faster.
Cardiology Emergency Medicine Neurology

Regulatory Status Disclosed

Overview

Vascular Assist Occlusion Triage (VAOT) is an AI-enabled medical device designed to assist radiologists in the rapid identification and prioritization of vascular occlusions. Developed by GuideAI Health, this tool leverages advanced artificial intelligence algorithms to analyze medical images, specifically focusing on detecting signs indicative of vascular blockages.

The primary goal of VAOT is to enhance the efficiency and accuracy of radiological triage in emergency settings. By providing an automated analysis, the system aims to reduce the time to diagnosis for critical conditions such as strokes or pulmonary embolisms, where timely intervention is paramount for patient outcomes. Physicians can integrate VAOT into their existing imaging workflows to augment their diagnostic capabilities.

VAOT is intended to serve as a supplementary tool, providing decision support rather than replacing the expertise of a qualified radiologist. It highlights potential areas of concern, allowing radiologists to focus their attention more effectively and potentially expedite the diagnostic process for patients presenting with symptoms of vascular occlusion.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered vascular occlusion detection
  • Radiological image analysis
  • Triage prioritization
  • Integration with existing PACS/RIS
  • Decision support for radiologists
  • Rapid identification of critical conditions

Use Cases

  • Expediting stroke diagnosis
  • Assisting in pulmonary embolism detection
  • Prioritizing emergency radiology reads
  • Improving workflow efficiency in vascular imaging
  • Supporting diagnosis of acute vascular events

What Physicians Need to Know

Evidence Base
VAOT is radiological computer-aided triage and notification software. It is indicated for use in the analysis of CTA studies of adult patients to assist in workflow prioritization by identifying imaging patterns consistent with possible total arterial occlusion within the aorta, common iliac, external iliac, common femoral, superficial femoral, and popliteal arteries. The device analyzes CTA images in parallel with the ongoing standard-of-care interpretation workflow. It is not a diagnostic tool and does not replace standard clinical interpretation.
Clinical Validation Studies
A retrospective, blinded, multicenter study of 317 cases (165 positive, 152 negative) from US clinical sites was conducted. Ground truth was established by 3 board-certified radiologists using majority voting. Primary endpoints showed a sensitivity of 0.915 (95% CI: 0.862, 0.953) and specificity of 0.901 (95% CI: 0.842, 0.944). In clinical performance testing supporting FDA clearance, the software achieved 95% patient-level sensitivity in 2D analysis and 94% in 3D analysis for identifying peripheral artery disease-positive patients (defined as those with at least one lesion at 50% or greater stenosis).
Alert Fatigue Management
When predefined criteria are met, VAOT generates a notification to alert the user that the case may warrant prioritization. These notifications may include compressed preview images for informational purposes only and are not intended for diagnostic use. The device aims to aid in prioritization and triage of radiological medical images only.
Clinical Workflow Integration
VAOT analyzes CTA images in parallel with the ongoing standard-of-care interpretation workflow. The device operates in parallel with standard-of-care workflows; it does not remove cases from worklists or alter original images. Radiologists use the notification to prioritize their reading queue. The results of VAOT are not intended for primary diagnosis, screening, disease detection, or patient management decisions; the interpreting clinician remains responsible for viewing the full imaging study according to standard clinical practice.
Decision Audit Trail
While specific details on VAOT's internal decision audit trail are not explicitly provided, clinical audits in general are recognized as providing valuable information for clinical practice improvements and can lead to small but important improvements when done properly. An audit's effectiveness depends on factors such as management support, baseline performance, trained personnel, data quality, frequency of auditing, and feedback processes.
Physician Tip

VAOT is a triage and notification tool, not a diagnostic one. Always confirm findings with a full review of the imaging study and integrate the alerts into your existing workflow for prioritizing cases. Remember that the device is intended to improve workflow efficiency by flagging potential occlusions, but the ultimate diagnostic and treatment decisions remain with the trained medical specialist.

VAOT is designed to integrate into hospital networks and existing imaging workflows. It sends notifications, potentially with compressed preview images, back to a Gateway, embeds them into a DICOM Secondary Capture, and routes them to the PACS. This allows for seamless incorporation into the radiologist's reading queue without altering original medical images or removing cases from worklists.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Unknown — unknown
DeploymentCloud-based, integrates seamlessly with existing imaging workflows (PACS).
Target SizeHospitals, radiology groups, and specialty practices.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

VascularAssist Occlusion Triage (VAOT) received FDA 510(k) clearance in June 2026 as a Class II Software as a Medical Device (SaMD). It is cleared for triage and notification of suspected peripheral arterial occlusion in lower-extremity CT scans.

Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Neurology, Radiology

Social Proof

Customersunknown
Notable
unknown

What the Web Says

Vascular Assist Occlusion Triage (VAOT) is an AI-powered software designed by GuideAI Health to identify and prioritize peripheral vascular disease (PVD) in lower-extremity CT scans. It functions as a Computer-Aided Triage and Notification (CADt) device, integrating into existing radiology workflows to help radiologists quickly flag and review potential cases of vascular occlusion. The software aims to reduce the time to diagnosis and intervention for patients at risk of acute or chronic limb ischemia. VAOT received FDA 510(k) clearance in June 2026, demonstrating robust accuracy with a patient-level sensitivity of 95% for 2D analysis and 94% for 3D analysis in identifying Peripheral Artery Disease with at least 50% stenosis.

Overall: Positive

Strengths

  • Enhances early detection and prioritization of peripheral vascular disease.
  • Integrates seamlessly with existing imaging workflows, requiring no new viewer or parallel queue.
  • Aims to reduce time to diagnosis and intervention for at-risk patients.
  • Demonstrated high accuracy in clinical performance evaluations (95% sensitivity for 2D, 94% for 3D).
  • FDA 510(k) cleared, providing a regulatory pathway for commercial deployment.
  • Built by interventional radiologists to reflect how vascular reads are actually performed.

Limitations

  • Regulatory clearance does not guarantee commercial adoption.
  • Specific physician, healthcare IT, or tech reviewer opinions are not yet widely available due to its recent FDA clearance and market entry.
  • No specific reviews or discussions found on Reddit, G2, or Capterra for VAOT itself (general discussions on vascular occlusion or AI in healthcare were found but not specific to VAOT).
  • The commercial opportunity depends on integration into hospital systems, radiology workflows, and reimbursement structures.

Based on reviews from: GuideAI Health Achieves FDA Clearance for AI-Based Vascular Triage Software, GuideAI Health (Cboe Canada:GDAI) Rises 7.14% as FDA-Cleared AI Vascular Software and Commercial Expansion Put Stock in Focus - Kalkine CA, Vascular Assist Occlusion Triage (VAOT) (v1.0) (K260729) u2014 FDA 510(k) | Innolitics, Detect peripheral arterial disease earlier u2014 GuideAI Health, GuideAI Health secures FDA clearance for vascular disease software - AuntMinnie

Last updated: 2026-09-24

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Press & Coverage

Innolitics
Vascular Assist Occlusion Triage (VAOT) (v1.0) (K260729) u2014 FDA 510(k)
GuideAI Health received FDA 510(k) clearance for its Vascular Assist Occlusion Triage (VAOT) (v1.0) software on June 18, 2026. This AI-powered device is designed to assist in workflow prioritization by identifying CTA images consistent with possible total arterial occlusion in the lower extremities.
2026-06
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos - Innolitics
The Vascular Assist Occlusion Triage (VAOT) (v1.0) by GuideAI Health was among the 86 AI/ML devices authorized by the FDA in Q2 2026, specifically on June 18, 2026. It is a radiological computer-aided triage and notification software that uses CTA images to alert radiologists to arterial occlusions, improving workflow efficiency.
2026-07
FDA
List of Artificial Intelligence-Enabled Medical Devices - FDA
The FDA's list of Artificial Intelligence-Enabled Medical Devices includes Vascular Assist Occlusion Triage (VAOT) (v1.0) by GuideAI Health, cleared on June 18, 2026, under product code QAS for Radiology. This list provides transparency for healthcare providers and patients regarding AI technologies in medical devices.
2026-09
FDA
K260729 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification document details the clearance of Vascular Assist Occlusion Triage (VAOT) (v1.0) by GuideAI Health on June 18, 2026, classifying it as a Class II radiological computer-aided triage and notification software. The document outlines the device's intended use and regulatory information.
2026-06
GuideAI Health
Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health ...
GuideAI Health's product page for Vascular Assist Occlusion Triage (VAOT) v1.0 provides a summary of its regulatory performance study and public source FDA notices. The software is designed for workflow prioritization in identifying arterial occlusions.
unknown
Rhizome AI
Competitive Intelligence | Rhizome AI
Rhizome AI's competitive intelligence data shows Vascular Assist Occlusion Triage (VAOT) was cleared on June 18, 2026, citing Aidoc BriefCase LVO Triage as a predicate device. This highlights the trend of AI/ML radiology devices citing similar functional class predicates.
2026-06

Videos

Product demos, reviews, and walkthroughs for Vascular Assist Occlusion Triage (VAOT).

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Frequently Asked Questions

VAOT is designed to integrate into existing imaging workflows, providing AI-powered detection and workflow support for healthcare providers. It assists with prioritizing and triaging suspected vascular occlusions in lower-extremity CT examinations, aiming to streamline the process for clinicians.
VAOT helps prioritize and triage suspected vascular occlusions in lower-extremity CT imaging. By providing AI-driven insights, it aims to facilitate timely notifications to specialists and improve care coordination, ultimately contributing to better patient outcomes.
While VAOT has received FDA 510(k) clearance, regulatory clearance does not guarantee commercial adoption. The effectiveness of similar AI-based virtual triage (VT) engines can vary across clinical specialties and settings, depending on the depth of disease-specific data used for training. Also, some studies suggest that clinical judgment should supplement risk assessment models.
Traditional methods for vascular access in emergencies include peripheral IVs, though these can be unsuccessful in a significant percentage of patients. Intraosseous (IO) access is another alternative for rapid vascular access in critical situations. While clinical judgment has been compared to triage scales for detecting large vessel occlusions in acute stroke, VAOT offers an AI-driven approach to assist with prioritizing and triaging based on CT imaging.
Specific pricing for VAOT is not publicly available. However, in the broader healthcare landscape, states like Vermont are implementing measures such as reference-based pricing and global hospital budgets to control healthcare costs, which could influence the adoption and pricing of new technologies like VAOT.
VAOT is designed to analyze lower-extremity CT imaging to assist with prioritizing and triaging suspected vascular occlusions. Generally, AI solutions for vascular care consolidate data and use AI to generate clinical insights for effective triage and notification of vascular disease.
By assisting with prioritizing and triaging suspected vascular occlusions, VAOT aims to facilitate earlier detection and more timely notifications to specialists. This can lead to faster routing and escalation of at-risk patients, potentially reducing delays in treatment and improving overall patient experience.

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Suggest an Edit → | Last Verified: 2026-09-23 | First Added: 2026-09-23
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