syngo.CT LVO Detection

by Siemens Medical Solutions USA  · Based in United States →AI-powered triage for rapid large vessel occlusion detection in stroke care.
Emergency Medicine Neurology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

syngo.CT LVO Detection is an AI-powered post-processing software designed to analyze CT angiography (CTA) head images. It assists clinicians in prioritizing cases by detecting suspected large vessel occlusions (LVO) in specific brain vessels, including the ICA, M1, and M2 segments. The software runs on the syngo.via platform and is intended to aid in triage, helping medical professionals manage stroke patients more efficiently. Its output is for informational purposes only and is not intended for standalone diagnostic use or to alter original medical images.

Performance testing demonstrated a sensitivity of 90.6% and specificity of 88.8% for LVO detection, with a median processing time of 42 seconds. The tool is designed for patients 22 years or older, without certain contraindications such as old infarcts, other diseases impacting brain vasculature (e.g., brain tumors), metal artifacts, or surgical signs in the images.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered post-processing software for CT angiography analysis
  • Detects suspected large vessel occlusions (LVO) in ICA, M1, and M2 segments
  • Supports computer-aided triage and case prioritization
  • Runs on the Siemens syngo.via platform
  • Provides output for informational purposes only, not for standalone diagnosis
  • Does not alter original medical images
  • Demonstrated high sensitivity (90.6%) and specificity (88.8%) in performance testing
  • Fast processing time (median 42 seconds, under 110 seconds)
  • Intended for patients 22 years or older without specific contraindications

Use Cases

  • Prioritizing acute stroke cases based on suspected LVO detection
  • Assisting clinicians in efficient management of stroke patients
  • Facilitating early identification and notification of LVO to treatment teams
  • Improving stroke workflow metrics and potentially accelerating treatment decisions

What Physicians Need to Know

Stroke Detection Speed
syngo.CT LVO Detection processes CT-angiography images with a median time of 42 seconds, typically under 110 seconds, to detect suspected large vessel occlusions. This rapid analysis aids in the prioritization of acute stroke cases, supporting faster clinical decision-making and potentially reducing door-to-treatment times.
Brain CT Analysis
The tool is an AI-powered post-processing software specifically designed for the analysis of CT angiography (CTA) head images. It utilizes artificial intelligence learning algorithms to identify suspected large vessel occlusions in the ICA, M1, and M2 segments. The software runs on the syngo.via platform and does not alter the original images, providing informational output for triage.
Large Vessel Occlusion Detection
syngo.CT LVO Detection is engineered to identify suspected large vessel occlusions (LVOs) in critical brain vessels, specifically the ICA, M1, and M2 segments. Performance testing demonstrated a sensitivity of 90.6% and specificity of 88.8% for LVO detection. The output is intended for informational purposes to support computer-aided triage, not for standalone diagnostic use.
Triage Prioritization Speed
The system supports computer-aided triage by promptly notifying users of suspected LVOs, which helps clinicians prioritize cases more efficiently. The implementation of similar automated LVO detection tools has been shown to significantly improve radiology CTA report turnaround times.
ASPECTS Score Automation
While syngo.CT LVO Detection focuses on LVO, the broader syngo.via platform includes 'syngo.CT ASPECTS' which automatically calculates the Alberta Stroke Program Early CT (ASPECT) score from non-contrast CT head scans. This feature highlights affected brain regions and supports the assessment of ischemic changes, providing consistent results independent of the user.
Mobile Notification System
The output from syngo.CT LVO Detection can be sent to an external notification device, enabling rapid communication of suspected LVO findings to the stroke team. This capability is crucial for accelerating the stroke workflow and facilitating timely intervention.
Physician Tip

Utilize syngo.CT LVO Detection as a critical AI-powered aid for rapid identification and prioritization of suspected large vessel occlusions in acute stroke patients. Remember that the tool provides informational support for triage and is not intended for standalone diagnosis; always integrate its findings with comprehensive clinical assessment and other imaging data. Leverage its speed to streamline workflow and facilitate quicker decision-making for potential thrombectomy candidates. Ensure seamless integration with your existing notification systems to maximize the benefit of early alerts.

syngo.CT LVO Detection operates on the syngo.via platform, Siemens Healthineers' advanced visualization and reporting solution. It is designed to integrate into existing CT workflows and can process images from various CT manufacturers. The system supports sending its output to external notification devices and integrates with Picture Archiving and Communication Systems (PACS) for automated result delivery. Siemens Healthineers also offers integrated solutions with partners on the syngo.via workstation, enhancing its ecosystem capabilities.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing Contact vendor for detailed pricing information.
DeploymentIntegrated within the syngo.via platform, typically deployed within hospital IT infrastructure (on-premise or hybrid).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

syngo.CT LVO Detection received FDA 510(k) clearance (K243145) on April 10, 2025. It is cleared as a radiological computer-assisted triage and notification software for identifying suspected large vessel occlusions in CTA head images.

Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

syngo.CT LVO Detection by Siemens Healthineers is an AI-powered software designed for the automated detection of large vessel occlusions (LVO) in contrast-enhanced CT scans of the head, primarily for patients suspected of acute ischemic stroke. It aims to assist radiologists in rapid detection and triage. The software has received FDA clearance and demonstrates high sensitivity and specificity in identifying LVOs, particularly in proximal vessels.

Overall: Positive

Strengths

  • High sensitivity (90.6%) and specificity (88.8%) for LVO detection.
  • Aids in reproducible detection of ICA, M1, and M2 vessel occlusions.
  • Supports computer-aided triage in stroke cases.
  • Demonstrated improved overall CTA report turnaround time in some studies.
  • Performs well across various CT scanner manufacturers and image qualities.
  • Potentially reduces the need for CTA and accelerates time to LVO diagnosis when used with NCCT.

Limitations

  • Sensitivity for M2-occlusions is lower compared to proximal vessel occlusions, especially in conventional CT.
  • May produce false positives, which could lead to alert fatigue or unnecessary transfers.
  • Performance seems to be better with Photon Counting CT (PCCT) data compared to conventional CT.
  • Some studies on similar tools have shown lower specificity, with concerns about false positives due to vascular asymmetry.
  • The output does not highlight or direct the reading physician's attention to any specific portion of the image.
  • Clinical outcomes were better in the pre-AI group for u0394NIHSS and NIHSS at discharge in one study, suggesting the need for further investigation into real-world impact on patient outcomes.

Based on reviews from: accessdata.fda.gov, ESR Connect, Innolitics, Radiology AI Tools Directory, Gob MX, American Heart Association Journals, PMC, Buyer shortlist

Last updated: 2026-07-19

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Press & Coverage

U.S. Food and Drug Administration (FDA)
syngo.CT LVO Detection 510(k) Clearance
Siemens Medical Solutions USA, Inc. received 510(k) clearance for syngo.CT LVO Detection, a radiological post-processing application for CT angiography head images to support computer-aided triage for large vessel occlusions in stroke patients.
2025-04
FDA.report
Radiological Computer-Assisted Triage And Notification Software QAS
syngo.CT LVO Detection by Siemens Medical Solutions USA, Inc. was listed under the product code QAS for radiological computer-assisted triage and notification software, indicating its role in prioritizing time-sensitive patient detection and diagnosis.
2025-04
Fortschritte auf dem Gebiet der Ru00f6ntgenstrahlen (RoFo)
Performance der KI-basierten Syngo.CT LVO Detection in der klinischen Notfalldiagnostik in Photon-Counting CT und konventioneller CT
This study investigated the sensitivity and specificity of syngo.CT LVO Detection in photon-counting CT and conventional CT for automated AI-supported detection of large vessel occlusions in suspected ischemic stroke patients.
2024
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
Siemens Medical Solutions USA, Inc.'s syngo.CT LVO Detection is mentioned among the AI/ML-related FDA clearances in 2025, specifically under the QAS product code for radiological computer-assisted triage and notification software.
2026-01
ESR Connect
Hot topics in emergency radiology - Assessment of Syngo.CT LVO: detection in photon counting CT and conventional CT
A presentation at ESR Connect discussed the assessment of syngo.CT LVO Detection, a prototype for AI-assisted detection of large vessel occlusion, comparing its performance in photon-counting CT and conventional CT.
2024
Gobierno de Mu00e9xico (COFEPRIS)
REGISTROS DE DISPOSITIVOS Mu00c9DICOS EXPEDIDOS EN 2025
syngo.CT LVO Detection by Siemens Healthcare Diagnostics, S. de R.L. de C.V. received a medical device registration in Mexico in May 2025, categorized as image analysis software for computed tomography datasets.
2025-05
Agu00eancia Nacional de Vigilu00e2ncia Sanitu00e1ria (ANVISA)
AGu00caNCIA NACIONAL DE VIGILu00c2NCIA SANITu00c1RIA 2u00aa DIRETORIA GERu00caNCIA-GERAL DE ALIMENTOS
Siemens Healthcare Diagnu00f3sticos Ltda. had an alteration of registration approved for syngo.CT LVO Detection in Brazil in April 2026, related to software changes including new indications and functionalities.
2026-04
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
syngo.CT LVO Detection from Siemens Medical Solutions USA, Inc. is cited as an example of how ground truth was established for AI/ML SaMD, involving independent assessments by neuroradiologists and adjudication by a third expert.
2025-09

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Frequently Asked Questions

syngo.CT LVO Detection is an AI-powered post-processing software designed to analyze CT angiography images and help prioritize suspected large vessel occlusion (LVO) cases for quicker review. Its intended role is to support computer-aided triage by notifying users of suspected LVOs, thereby aiming to improve workflow efficiency and reduce time to treatment in acute stroke management.
The software is specifically designed to detect suspected large vessel occlusions in the Internal Carotid Artery (ICA), M1, and M2 segments of the brain. Performance testing has demonstrated a sensitivity of 90.6% and specificity of 88.8% for LVO detection. However, it is crucial to note that it is not intended for standalone diagnosis and should complement, not replace, a radiologist's interpretation.
Yes, syngo.CT LVO Detection has received FDA approval as an AI-powered radiological post-processing application intended for computer-aided triage. The FDA explicitly states that such software is for prioritization and triage only, not for standalone diagnostic decisions or to rule out LVOs, and all imaging exams still require interpretation by a qualified imaging physician.
Several other AI-powered LVO detection tools are available in the market, such as Viz LVO and Rapid LVO (RapidAI), which also aim to assist in stroke triage. Comparative studies suggest that performance metrics, including sensitivity and specificity for LVO detection, can vary among these different AI solutions.
While specific pricing details for syngo.CT LVO Detection are not publicly detailed, AI-based LVO detection software typically involves a cost per analysis. Analyses suggest that these technologies can lead to potential annual healthcare system savings by reducing missed diagnoses and improving treatment times. Furthermore, the U.S. Centers for Medicare and Medicaid Services (CMS) has provided New Technology Add-on Payments (NTAP) for AI-based LVO stroke detection, which can influence reimbursement.
A primary limitation is that the software is intended solely for triage and informational purposes, not for definitive diagnosis or alteration of original images. There is a risk of false negatives, meaning LVOs could be missed, and the FDA explicitly advises against using AI applications to exclude LVO cases from a radiologist's comprehensive review.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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