syngo.CT Brain Hemorrhage

by Siemens Medical Solutions USA  · Based in United States →AI-powered software for rapid detection and prioritization of brain hemorrhages on CT scans.
Emergency Medicine Neurology Radiology

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Regulatory Status Disclosed

Overview

syngo.CT Brain Hemorrhage is an advanced AI-powered software solution developed by Siemens Medical Solutions USA, designed to assist radiologists in the rapid identification and prioritization of suspected intracranial hemorrhage (ICH) and subarachnoid hemorrhage (SAH) on non-contrast head CT examinations.

This image-processing software utilizes artificial intelligence algorithms to analyze CT images and flag cases for earlier review, thereby improving workflow efficiency in emergency settings. It operates as a notification-only tool, making case-level output available to a CT scanner or other PACS system for worklist prioritization. It is important to note that the output is intended for informational purposes only and is not for diagnostic use; the device does not alter the original medical image and is not intended to be used as a standalone diagnostic device.

Additionally, a related application, syngo.CT DE Brain Hemorrhage, leverages dual-energy CT to generate virtual non-contrast images from contrast-enhanced scans, potentially avoiding the need for a separate unenhanced CT scan. This functionality aids in the visualization of iodine concentration and distribution in the brain, helping to differentiate hemorrhage from iodine uptaking lesions or post-interventional bleeding from transient iodine uptake.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered detection of acute intracranial hemorrhage (ICH) and subarachnoid hemorrhage (SAH)
  • Prioritization of CT scans for urgent review in radiology workflow
  • Generates virtual non-contrast images from contrast-enhanced dual energy scans (syngo.CT DE Brain Hemorrhage)
  • Aids in differentiation of hemorrhage and iodine uptaking lesions (syngo.CT DE Brain Hemorrhage)
  • Supports analysis of DICOM images from Siemens and other vendors
  • Compatible with SOMARIS-X and syngo.via platforms
  • Notification-only tool; does not alter original medical images
  • High sensitivity (95.0% for ICH, 86.1% for SAH) and specificity (93.1% for ICH, 85.2% for SAH)
  • Average processing time of 13.34 seconds per case

Use Cases

  • Accelerating workflow for radiologists in emergency departments
  • Assisting in the rapid identification of acute intracranial and subarachnoid hemorrhages
  • Prioritizing cases of suspected brain hemorrhage for earlier clinical review
  • Reducing the need for additional non-contrast CT scans by creating virtual non-contrast images from dual-energy data
  • Differentiating post-interventional bleeding from transient iodine uptake in neuro-interventional procedures

What Physicians Need to Know

Stroke Detection Speed
Offers enhanced detection of intracranial hemorrhages on non-contrast CT scans with 93.6% sensitivity and 99.2% negative predictive value for intracranial hemorrhage. It aims to expedite stroke diagnosis and treatment by quickly answering crucial diagnostic questions, potentially reducing door-to-needle times.
Brain CT Analysis
Specifically designed for CT analysis, including non-contrast CT and dual-energy CT. It can generate virtual non-contrast images from contrast-enhanced dual-energy scans, potentially avoiding additional scans. The tool aids in differentiating hemorrhage from iodine-uptaking lesions and identifies acute intracranial hemorrhage (ICH) and acute subarachnoid hemorrhage (SAH).
Triage Prioritization Speed
Assists radiologists in prioritizing cases of suspected intracranial hemorrhage by providing case-level output to CT scanners or PACS systems for worklist prioritization. The deep learning software can effectively preselect and flag conspicuous findings with a low false negative rate, supporting workload reduction and timely review of critical cases.
Mobile Notification System
Includes a finding notification mechanism and makes case-level output available to CT scanners or PACS systems for worklist prioritization, facilitating rapid communication of critical findings.
Physician Tip

Leverage the virtual non-contrast images from dual-energy CT to potentially reduce the need for additional scans and associated radiation dose. Utilize the AI's high sensitivity and negative predictive value for intracranial hemorrhage to confidently rule out hemorrhage in many cases and prioritize those with suspected bleeding. Be aware that the tool aids in differentiating hemorrhage from iodine-uptaking lesions, which is crucial for accurate diagnosis. Integrate the AI's prioritization capabilities into your workflow to manage high volumes and ensure timely review of critical cases. Remember that the AI output is for informational purposes and triage, not for standalone diagnostic use, and radiologist confirmation is still required.

syngo.CT Brain Hemorrhage integrates with Siemens Healthineers CT scanners (e.g., SOMATOM Edge eco, SOMATOM Definition Edge) and syngo.via software (VA11 or higher, VA20B, VA30, VB40, VB60). It provides case-level output to CT scanners or PACS systems for worklist prioritization. The tool is part of the broader 'CT Neuro Engine' which offers a comprehensive diagnostic stroke solution and can be used in conjunction with other syngo.CT applications for an integrated workflow.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact vendor
  • Pricing information is not publicly available
  • Please contact Siemens Medical Solutions USA for details
DeploymentOn-premise, integrated with CT scanners and PACS/syngo.via systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Cleared by the FDA under K232431 on March 22, 2024, as an AI-powered radiological computer-assisted triage and notification software for suspected intracranial and subarachnoid hemorrhages on non-contrast head CT examinations.

Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

syngo.CT Brain Hemorrhage is a deep learning AI software developed by Siemens Healthineers designed to assist radiologists in detecting and prioritizing cases of suspected intracranial hemorrhage (ICH) on non-contrast CT scans. It has demonstrated high diagnostic performance, with studies showing strong accuracy, sensitivity, and negative predictive value for ICH detection. The software aims to augment clinical workflow, reduce errors, and prioritize clinically relevant cases, especially in high-volume or understaffed settings.

Overall: Positive

Strengths

  • High diagnostic performance for ICH detection, with reported sensitivity rates of 93.6% to 98.1% and specificity rates of 89.7% to 96.2%.
  • Excellent negative predictive value (NPV) of up to 99.7%, indicating high reliability in ruling out hemorrhage.
  • Ability to detect ICH cases missed in initial radiologist review, improving accuracy and reducing errors.
  • Potential for workload reduction and prioritization of clinically relevant cases, particularly in busy environments.
  • Fast processing time, making it a valuable triage tool.
  • Accurate identification of various intracranial hemorrhage subtypes, including intraparenchymal, epidural, subarachnoid, and intraventricular hemorrhage.

Limitations

  • The device is intended for informational purposes only and not for standalone diagnostic use.
  • Its use should be limited to CT scans acquired on General Electric (GE) or its subsidiaries (e.g., GE Healthcare) equipment; use with CT scans from other manufacturers has not been validated or recommended.
  • Some studies show a lower positive predictive value (PPV), with one study reporting 39 false positives out of 52 positive cases.
  • Lower sensitivity and specificity for subarachnoid hemorrhage (SAH) compared to overall ICH detection in some analyses.

Based on reviews from: Insights into Imaging, Innolitics, PMC (PubMed Central), Stroke: Vascular and Interventional Neurology, American College of Radiology, MDPI, ResearchGate, IntuitionLabs, Diagnostic Imaging

Last updated: 2026-07-19

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Press & Coverage

Diagnostic Imaging
Can Deep Learning Enhance Non-Contrast CT Detection of Intracranial Hemorrhages?
A recent study published in Insights into Imaging found that the AI software syngo.CT Brain Hemorrhage VB60 (Siemens Healthineers) demonstrated high sensitivity (93.6%) and specificity (96.2%) for detecting intracranial hemorrhage on non-contrast cranial CT scans. The software also identified 12 cases of ICH that were initially missed by radiologists, suggesting its potential for workload reduction and improved diagnostic accuracy.
2026-03
Siemens Healthineers
Tackling stroke with speed and precision - Siemens Healthineers
Siemens Healthineers highlights syngo.CT Brain Hemorrhage as a software application that assists in the detection and evaluation of brain hemorrhages using CT imaging. This tool provides automated capabilities to identify and assess hemorrhagic lesions, aiming to improve diagnostic accuracy and efficiency in stroke care.
unknown
PMC (PubMed Central)
Revolutionizing Acute Stroke Care: A Review of Food and Drug Administration-Approved Software as Medical Devices for Stroke Triage - PMC
A review of FDA-approved Software as Medical Devices for stroke triage, published in November 2024, includes Siemens Medical Solutions USA, Inc.'s syngo.CT Brain Hemorrhage. The device is noted for its high sensitivity (95% for ICH, 86.1% for SAH) and specificity (93.1% for ICH, 85.2% for SAH) in detecting intracranial and subarachnoid hemorrhages on non-contrast head CT scans, with an average processing time of 13.34 seconds.
2024-11
American College of Radiology
AI Central Market Updates for May 15, 2024 - American College of Radiology
The American College of Radiology's AI Central updated its directory in May 2024 to include syngo.CT Brain Hemorrhage by Siemens Healthineers. The software is designed to help radiologists prioritize suspected intracranial hemorrhage cases on non-contrast CT scans by providing case-level output for worklist prioritization.
2024-05
Stroke: Vascular and Interventional Neurology
Evaluation of an Artificial Intelligence Model for Identification of Intracranial Hemorrhage Subtypes on Computed Tomography of the Head | Stroke: Vascular and Interventional Neurology
A May 2024 study evaluated an AI model, which includes the technology behind syngo.CT Brain Hemorrhage, for identifying intracranial hemorrhage subtypes on head CT. The model demonstrated accurate identification of various hemorrhage subtypes, with high AUC values for acute subdural/epidural hematoma, subarachnoid hemorrhage, intra-axial hemorrhage, and intraventricular hemorrhage.
2024-05
FDA.report
Siemens Medical Solutions USA, Inc. Monsuru Bello Regulatory Affairs Specialist 810 Innovation Drive Knoxville, TN 37932 Re - FDA.report
A March 2024 FDA document confirms that syngo.CT Brain Hemorrhage is considered a safe and effective triage and notification device for intracranial hemorrhages. The document details performance goals, noting that sensitivity and specificity exceeded 80% for both intracranial and subarachnoid hemorrhage triage.
2024-03
MDPI
Diagnostic Accuracy and Performance Analysis of a Scanner-Integrated Artificial Intelligence Model for the Detection of Intracranial Hemorrhages in a Traumatology Emergency Department - MDPI
A November 2023 study assessed the diagnostic accuracy of 'Brain Hemorrhage,' a CE-labeled Deep-Learning-Algorithm by Siemens Healthineers. The algorithm, integrated into CT scanners, automatically identifies suspicious datasets for intracranial hemorrhage, with results calculated without further interaction and provided as read-only.
2023-11
IntuitionLabs
FDA AI/ML SaMD Guidance: Complete 2026 Compliance Guide | IntuitionLabs
A July 2026 article discussing FDA's AI/ML SaMD guidance highlights the Siemens syngo.CT Brain Hemorrhage analyzer as an example of an FDA-cleared stroke-triage algorithm. It notes the device's clinical testing demonstrated 92.8% sensitivity and 94.5% specificity in automatically detecting intracranial hemorrhage on CT scans.
2026-07

Videos

Product demos, reviews, and walkthroughs for syngo.CT Brain Hemorrhage.

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Frequently Asked Questions

syngo.CT Brain Hemorrhage is an AI-powered image-processing software designed to assist radiologists in prioritizing cases of suspected intracranial hemorrhage (ICH) on non-contrast CT examinations of the head. It facilitates a parallel workflow by flagging cases suspicious for acute ICH or subarachnoid hemorrhage (SAH) for prioritized review, making case-level output available to a CT scanner or PACS system.
The AI algorithm in syngo.CT Brain Hemorrhage uses deep learning to identify findings suspicious of acute intracranial hemorrhage, including various subtypes. Studies have shown high diagnostic performance, with reported sensitivities for overall ICH detection ranging from 88.8% to 95.0% and specificities from 92.1% to 96.2%, and a high negative predictive value of up to 99.2%.
syngo.CT Brain Hemorrhage has received FDA clearance as a radiological computer-assisted triage and notification software. It is intended for informational purposes only and is not designed for diagnostic use as a standalone device, nor does it alter the original medical image.
Alternatives include traditional interpretation by radiologists, who remain the gold standard for diagnosing intracranial hemorrhage. Other commercially available AI-based detection tools exist, such as qER.ai, which also aim to assist in the rapid evaluation and prioritization of non-contrast CT scans for ICH.
While specific pricing is not publicly disclosed, Siemens Healthineers generally offers flexible licensing models for its syngo.via software, which includes applications like syngo.CT Brain Hemorrhage. These models, such as the syngo.via Flex Plan, are designed to adapt to a department's budget, tasks, and clinical focus.
The AI is a triage and notification tool, not a standalone diagnostic device, and its output is for informational purposes only. Studies have noted that while overall accuracy is high, the tool may yield lower detection rates for specific subtypes of ICH, and false positives can occur due to postoperative changes, artifacts, or tumors.
The dual-energy version, syngo.CT DE Brain Hemorrhage, has the potential to differentiate between old and new intracranial bleedings and assists in visualizing iodine concentration to distinguish hemorrhage from iodine-uptaking lesions. The AI algorithm also classifies hemorrhage subtypes, though specificity for subtype classification can be lower than for overall hemorrhage detection.

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