Brainomix 360 Triage Stroke

by Brainomix Limited  · Based in United Kingdom → — Precision AI for Time-Sensitive Stroke Care
Emergency Medicine Neurology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Brainomix 360 Triage Stroke is a radiological computer-aided triage and notification software designed to assist hospital networks and trained clinicians in workflow prioritization. It analyzes non-contrast CT (NCCT) images to flag and communicate suspected positive findings of large vessel occlusion (LVO) and intracranial hemorrhage (ICH) in real-time. This tool enables physicians across stroke networks to access expert-level insights from universally available non-contrast CT scans, improving decision-making for treatment and transfer of patients. The software sends real-time alerts directly to clinicians’ smartphones, facilitating faster treatment decisions for stroke patients. Brainomix 360 Triage Stroke is part of the broader Brainomix 360 platform, which aims to optimize workflow across stroke networks and support consistent, high-quality stroke care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time alerts for suspected LVO and ICH
  • Analysis of non-contrast CT (NCCT) scans
  • Smartphone notifications for critical findings
  • Workflow triage and prioritization
  • DICOM compliant processing
  • Automated image processing
  • Supports treatment and transfer decisions
  • Cloud-based and on-premise deployment options
  • Mobile app for secure access and sharing
  • Integration with PACS

Use Cases

  • Expediting treatment decisions for acute stroke patients
  • Optimizing workflow across stroke networks
  • Supporting transfer decisions for patients requiring specialized care
  • Identifying patients eligible for mechanical thrombectomy and thrombolysis
  • Reducing door-in-door-out (DIDO) times in primary stroke centers
  • Standardizing stroke assessment across diverse care settings

What Physicians Need to Know

Stroke Detection Speed
Provides real-time alerts for suspected large vessel occlusion (LVO) and intracranial hemorrhage (ICH). Imaging interpretation with AI use was significantly faster in a simulation (2.1 minutes compared to 3.4 minutes without AI). Detection of ICH and LVO on NCCT can range from 62 to 134 seconds.
Brain MRI/CT Analysis
Analyzes non-contrast CT (NCCT) for LVO, ICH, and ASPECTS score, CT angiography (CTA) for LVO detection and collateral assessment, CT perfusion (CTP) for core and penumbra volumes, and MRI (DWI and DSC perfusion) for advanced imaging assessments.
Large Vessel Occlusion Detection
Detects LVO on both non-contrast CT (NCCT) and CT angiography (CTA) scans. The Triage LVO module is FDA-cleared for real-time alerts of suspected LVO.
Triage Prioritization Speed
Designed to optimize workflow across stroke networks, facilitating faster treatment and transfer decisions. Studies show a reduction in door-in-door-out (DIDO) times by over an hour, and a 61-minute reduction in DIDO time at primary stroke centers.
ASPECTS Score Automation
The e-ASPECTS module fully automates and standardizes the Alberta Stroke Program Early CT Score (ASPECTS) from non-contrast CT scans, providing a heatmap and segmentation of affected regions.
Mobile Notification System
Provides real-time alerts of suspected LVO and ICH directly to clinicians' smartphones via a mobile app (Android and iOS) and web user interface. Notifications include compressed preview images for informational purposes.
Physician Tip

Leverage Brainomix 360 Triage Stroke to expedite decision-making for acute stroke patients, especially in non-specialist centers, by utilizing its real-time AI insights from various imaging modalities (NCCT, CTA, CTP, MRI). The automated ASPECTS scoring and LVO/ICH detection can enhance diagnostic confidence and streamline patient triage and transfer, potentially increasing access to time-sensitive treatments like mechanical thrombectomy and thrombolysis. Always confirm findings with full diagnostic images and integrate AI insights with comprehensive clinical judgment.

Brainomix 360 Triage Stroke is a DICOM-compliant software that integrates into existing hospital networks. It supports images from Siemens, GE, and Philips scanners and facilitates secure communication and data sharing between clinicians across a network via its cloud platform and mobile app, optimizing workflow for faster treatment and transfer decisions.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentOn-premise VM, physical server, cloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Brainomix 360 Triage Stroke received FDA clearance under K251983, with a letter date of August 26, 2025, as a radiological computer-assisted triage and notification software.

Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

Brainomix 360 Triage Stroke is an AI-powered imaging platform designed to assist physicians in making faster and more confident treatment decisions for stroke patients. It provides real-time interpretation of brain scans, including non-contrast CT (NCCT), CT angiography (CTA), and CT/MR perfusion, to guide treatment and transfer decisions. The software has been widely adopted in the UK and Europe and has received FDA clearance in the US, with studies demonstrating its effectiveness in improving patient outcomes and streamlining stroke care pathways.

Overall: Positive

Strengths

  • Significantly reduces door-in-door-out (DIDO) times and other treatment delays, leading to faster diagnosis and treatment.
  • Increases rates of life-saving treatments like mechanical thrombectomy and intravenous thrombolysis.
  • Improves diagnostic accuracy and physician confidence in treatment decisions, especially for non-stroke specialists.
  • Expands access to advanced stroke care, particularly in primary stroke centers and hospitals with fewer specialist doctors.
  • Provides automated analysis of various imaging modalities, including NCCT, CTA, and CT/MR perfusion, with high accuracy for identifying acute hemorrhage and large vessel occlusions.
  • Offers a mobile app for quick and secure access to critical results, facilitating communication and workflow optimization across networks.

Limitations

  • Mobile app is for informational purposes only and not for diagnostic decision-making.
  • Not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions.
  • Does not replace the need for CTA in ischemic stroke workup; it provides workflow prioritization and notification only.
  • False negatives in identifying acute ischemia and large vessel occlusions highlight the ongoing need for clinician review of CT imaging.
  • Accuracy for identifying hyperdense thrombus was lower due to many false positives.
  • Validated and intended for use on Siemens, GE, and Philips scanners, which might imply limitations with other scanner types.

Based on reviews from: Brainomix, Cureus, Diagnostic and Interventional Cardiology, pharmaphorum, Blackford Analysis, PR Newswire, BIA, NeuroNews, Reddit, accessdata.fda.gov, MDPI, App Store, Google Play, PubMed

Last updated: 2026-07-17

Ratings & Reviews

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Press & Coverage

Brainomix
Brainomix 360 Triage Stroke Receives FDA Clearance
Brainomix 360 Triage Stroke, an AI-powered tool, received FDA clearance to generate critical information from non-contrast CT scans, alerting clinicians of suspected large vessel occlusions (LVO) and intracranial hemorrhages (ICH) to support treatment and transfer decisions.
2024-01
AuntMinnie.com
Brainomix stroke software granted FDA clearance
The FDA granted 510(k) clearance to Brainomix for a patented feature within its AI-enabled 360 Stroke software, allowing assessment of ischemic core volume on non-contrast CT scans to improve decision-making for stroke patient triage and treatment.
2025-04
Brainomix
Brainomix Advances Stroke Care with Landmark FDA Clearance
Brainomix announced FDA clearance of a novel feature for its Brainomix 360 Stroke solution, enabling physicians to assess ischemic core volume from non-contrast CT images, which has been validated by leading US stroke centers.
2025-04
NeuroNews
Brainomix to launch next-generation stroke platform equipped with net water uptake technology
Brainomix is set to launch its new Brainomix 360 next-generation platform at the International Stroke Conference (ISC) 2026, featuring a first-of-its-kind net water uptake (NWU) capability using routine non-contrast CT scans.
2026-02
PR Newswire
Brainomix Launches Award-Winning Next Generation Stroke AI Platform with Novel Net Water Uptake Technology at the International Stroke Conference (ISC)
Brainomix launched its new Brainomix 360 Next Generation platform at the International Stroke Conference, incorporating a novel net water uptake capability and receiving a Red Dot Design Award for its user experience.
2026-02
Diagnostic and Interventional Cardiology
Study Shows How AI is Transforming Stroke Care
A prospective real-world study published in The Lancet Digital Health demonstrated that Brainomix 360 Stroke significantly increased rates of endovascular thrombectomy treatment and reduced delays in patient triage and transfer.
2025-12
BioIndustry Association | BIA
Brainomix demonstrates impact of Brainomix 360 Stroke to increase endovascular thrombectomy rates
A study published in The Lancet Digital Health showed that the Brainomix 360 Stroke AI imaging platform led to a 100% increase in endovascular thrombectomy rates at sites using the software, compared to a 63% increase at non-evaluation sites.
2025-12
Brainomix
Revolutionizing Acute Stroke Care: A Review of Food and Drug Administration-Approved Software as Medical Devices for Stroke Triage
This review explores the integration of AI and machine learning into medical devices for stroke triaging, including Brainomix 360, highlighting their impact on reducing notification times, latency in care, and health disparities.
2024-11

Videos

Product demos, reviews, and walkthroughs for Brainomix 360 Triage Stroke.

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Frequently Asked Questions

Brainomix 360 Stroke integrates into existing workflows by providing real-time AI-driven interpretation of brain scans (NCCT, CTA, CTP, MRI) to guide acute stroke treatment and transfer decisions. Key features include automated detection of large vessel occlusion (LVO) and intracranial hemorrhage (ICH), ASPECTS scoring, and core/penumbra volume estimation, accessible via a mobile app for rapid communication across stroke networks.
Brainomix 360 Stroke holds FDA clearance and CE Mark certification, affirming its compliance with medical device regulations in the US and Europe. While specific HIPAA/GDPR details were not explicitly found, the FDA clearance document indicates adherence to FDA Cybersecurity Guidance and IEC 81001-5-1, which typically cover data security and privacy.
Primary alternatives to Brainomix 360 Triage Stroke include RapidAI, Viz.ai, and Aidoc, all offering AI-powered stroke imaging analysis. Brainomix is recognized for its extensive validation in automated NCCT ASPECTS and network deployments, while other platforms may focus on perfusion parameters, door-to-puncture time reductions, or worklist prioritization.
The search results do not explicitly detail the typical pricing model for Brainomix 360 Triage Stroke. However, economic analyses suggest that AI in stroke imaging can be cost-effective by improving functional outcomes and expanding access to thrombectomy, rather than primarily through labor substitution. Factors influencing overall cost likely include the scale of deployment, specific modules utilized, and patient volume.
Known limitations of AI stroke platforms generally include variability in CTP outputs across systems and susceptibility of perfusion analyses to artifacts. For Brainomix, some literature notes a smaller volume of validation data in clinical contexts strictly relying on perfusion criteria common in certain U.S. centers. Physicians must maintain careful oversight, as the software is an assistive tool, not a rule-out device, and has limitations regarding detection of certain pathologies like isolated subarachnoid hemorrhage or tumors.
Brainomix provides support for physicians and staff to effectively use the 360 Triage Stroke platform, as indicated by 'Support' resources available on their website. However, the specific nature, duration, or format of these training and support programs were not detailed in the provided search results.
Brainomix 360 Stroke demonstrates clinical efficacy by significantly increasing rates of endovascular thrombectomy and intravenous thrombolysis, and by reducing delays in patient triage and transfer. Studies show its use is associated with improved patient outcomes, including less severe disability at discharge and a higher likelihood of achieving functional independence.

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Brainomix 360 Triage ICH is an FDA-cleared AI tool that provides real-time, smartphone-based alerts of suspected intracranial hemorrhage (ICH) from non-contrast CT scans, aiding rapid clinical triage and stroke treatment decisions.
Brainomix 360 Triage LVO
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Brainomix 360 Triage LVO is an FDA-cleared AI-powered notification tool providing real-time alerts of suspected large vessel occlusion (LVO) to clinicians on their smartphones, evaluating CT angiography scans for critical stroke indicators.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17

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