Brainomix 360 Hyperdensity

by Brainomix Limited  · Based in United Kingdom → — AI-Powered Brain & Lung Imaging
Emergency Medicine Neurology Radiology

Overview

Brainomix 360 Hyperdensity is a component of the Brainomix 360 Stroke AI platform, which provides real-time interpretation of brain scans across various modalities, including Non-Contrast CT (NCCT), CT Angiography (CTA), CT Perfusion (CTP), and MRI.

  • What it does: Specifically, the Brainomix 360 Hyperdensity feature, as part of the NCCT analysis, calculates the ASPECTS score and highlights regions with hyper- and hypodensities. It also assesses ischemic core based on net water uptake from standard imaging, with results comparable to CT Perfusion and MRI. The software is designed to detect the hyperdense artery sign (HAS), which can indicate a large vessel occlusion (LVO) in acute ischemic stroke patients. It also flags suspected intracranial hemorrhages (ICH).
  • Who it is for: This tool is intended for hospital networks and trained clinicians, including stroke specialists, radiologists, and interventionalists, involved in the acute stroke pathway. It is used in care settings where rapid assessment of stroke imaging is critical.
  • How it fits a clinical or practice workflow: After a routine NCCT scan is acquired, it is automatically sent to Brainomix for AI-powered analysis, with results delivered to clinicians via PACS, mobile app, email, or web UI within minutes. This aims to streamline workflows, facilitate faster treatment decisions, and improve communication among stroke teams. The mobile app allows for secure access, review, and sharing of images and patient data, and can be used to signal patient eligibility for thrombectomy.
  • Notable capabilities: Key capabilities include automated ASPECTS scoring, acute hypodensity heatmap, and the ability to flag suspected LVOs and ICH. It also provides automated quantification of collaterals and core volume assessment from NCCT, which may assist clinical assessment when CTP or MRI are not readily available. The software can also estimate thrombus length on NCCT. Brainomix 360 Stroke is designed to provide real-time smartphone alerts for suspected large vessel occlusions and intracranial hemorrhages.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated detection and quantification of brain hyperdensities on CT scans
  • AI-powered interpretation of brain scans across NCCT, CTA, CTP, and MRI
  • Automated ASPECTS scoring
  • Hyperdense Vessel Sign (segmentation + length)
  • NCCT Core Volume assessment
  • Acute Hypodensity Heatmap
  • ICH Detection, Volume, and Mask
  • Real-time alerts for suspected Large Vessel Occlusion (LVO) and intracranial hemorrhage (ICH)
  • PACS integration
  • Mobile app access for results and communication

Use Cases

  • Rapid assessment of acute ischemic stroke patients
  • Assisting clinicians in making time-sensitive treatment and transfer decisions for stroke patients
  • Workflow triage by flagging and communicating suspected positive findings of head NCCT images for LVO or ICH
  • Expanding patient access to life-changing treatments like thrombolysis and mechanical thrombectomy
  • Supporting imaging-based treatment decisions across the stroke pathway
  • Enhancing and standardizing ASPECTS scoring

What Physicians Need to Know

Stroke Detection Speed
Brainomix 360 Stroke harnesses AI to interpret brain scans in minutes, significantly improving access to life-saving stroke therapies. It can deliver results within minutes of a scan being acquired, with automated processing taking as little as 60 seconds for NCCT scans.
Brain MRI/CT Analysis
Brainomix 360 provides comprehensive AI stroke imaging across NCCT, CTA, CTP, and MRI modalities. For Non-Contrast CT (NCCT), it calculates ASPECTS scores, highlights hyper- and hypodensities, assesses ischemic core volume, and detects suspected large vessel occlusions (LVOs) and intracranial hemorrhages (ICH). CT Angiography (CTA) analysis includes automatic LVO detection, collateral scoring with heatmaps, and multi-planar reconstructions. CT Perfusion (CTP) generates visual reports with metrics like mismatch ratio, Tmax >6s, and rCBF <30%, helping to identify salvageable brain tissue. For MRI, it enables side-by-side visualization of DWI, ADC, b=0, b=max, and perfusion sequences, and delivers DWI-FLAIR mismatch analysis for late-window treatment candidates.
Large Vessel Occlusion Detection
Brainomix 360 automatically detects suspected Large Vessel Occlusions (LVOs) on both NCCT and CTA scans. On NCCT, it uses a combined analysis of ASPECTS and hyperdense vessel sign (HDVS) algorithms. For CTA, it pinpoints occlusion locations and provides objective collateral scoring.
Triage Prioritization Speed
The system provides priority notifications to clinicians for suspected LVO or ICH based on positive findings. This assists hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings for LVO and ICH. This can lead to a significant reduction in door-in-door-out (DIDO) times, with studies showing reductions of over an hour or 49-65 minutes.
ASPECTS Score Automation
Brainomix 360 automatically calculates the ASPECTS score from non-contrast CT scans, highlighting affected brain regions and areas with hyper- and hypodensities. It features explainable AI and a heatmap for nuanced assessment.
Mobile Notification System
The Brainomix 360 Mobile app provides physicians with quick, secure access to AI-powered scan results on iOS or Android devices, or via a web browser. It allows for viewing AI-processed scan results, including pseudonymized patient data, and enables clinicians to signal patient eligibility for thrombectomy with a single swipe, instantly notifying the relevant clinical team. The app also supports secure messaging and calling for care coordination. Mobile app images are compressed previews and not intended for diagnostic use.
Physician Tip

Brainomix 360 Hyperdensity is a powerful tool for rapid stroke assessment, particularly for identifying large vessel occlusions and intracranial hemorrhages from NCCT and CTA scans. Leverage the automated ASPECTS scoring and hypodensity heatmaps for quick initial evaluations. The mobile notification system is crucial for accelerating communication and decision-making within stroke networks, but remember that mobile images are for preview and triage, not primary diagnosis. Integrate the AI-powered insights with your clinical judgment and other patient information for comprehensive treatment decisions. The platform's ability to provide core volume assessment from NCCT can be particularly beneficial in settings where CTP or MRI may not be immediately available.

Brainomix 360 can be deployed on a dedicated physical server, a virtual server, or in a secure cloud environment. Results are delivered directly to clinicians via PACS, mobile app, email, or web UI within minutes of the scan being acquired. It is compliant with the DICOM standard and works with existing enterprise directories, including LDAP, Microsoft AD, and Single Sign-On, with multi-factor authentication. Patient data is pseudonymized and encrypted. The system has been validated for use with Siemens, GE, and Philips scanners.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Unknown — unknown
DeploymentPhysical server, virtual server, or cloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

Brainomix 360 e-ASPECTS, a component of the Brainomix 360 platform, received FDA clearance as a computer-aided diagnosis (CADx) software device to assist clinicians in assessing and characterizing brain tissue abnormalities using CT image data. Additionally, Brainomix has received FDA clearance for a feature that enables physicians to assess ischemic core volume from non-contrast CT (NCCT) images through the Brainomix 360 Stroke solution.

Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

Brainomix 360 Hyperdensity is part of the Brainomix 360 Stroke platform, an AI-powered imaging solution designed to assist clinicians in making faster and more informed treatment decisions for stroke patients. It analyzes non-contrast CT (NCCT) scans to identify hyperdense volumes associated with acute intracranial hemorrhage (ICH) and hyperattenuation in vessels and hypodense regions linked to large vessel occlusion (LVO). The software aims to improve patient outcomes by streamlining workflows, reducing treatment times, and expanding access to life-saving stroke therapies like mechanical thrombectomy.

Overall: Positive

Strengths

  • Calculates ASPECTS score and highlights hyper/hypodensities on NCCT.
  • Detects large vessel occlusions and intracranial hemorrhages, sending real-time smartphone alerts.
  • Reduces door-in-door-out times at primary stroke units and increases mechanical thrombectomy rates.
  • Provides results equivalent to CT Perfusion and MRI from standard imaging alone.
  • Offers secure access to AI-powered scan results via mobile app, web app, and email, facilitating communication and care coordination.
  • Demonstrated high accuracy in identifying acute hemorrhage (97.8%) and large vessel occlusions (91.5%).

Limitations

  • Not intended to detect isolated subarachnoid hemorrhage or symmetrical bilateral MCA occlusions.
  • Mobile app images are compressed previews and not for diagnostic use beyond notification.
  • Does not replace the need for CTA in ischemic stroke workup; it provides workflow prioritization and notification only.
  • Should be used as an adjunct to expert interpretation rather than a standalone decision-making tool.
  • Accuracy for identifying hyperdense thrombus was lower (69.1%) due to many false positives.

Based on reviews from: Brainomix, accessdata.fda.gov, NeuroNews International, Blackford Analysis, MDPI, Diagnostic and Interventional Cardiology, Oxford University Innovation, Reddit, BioIndustry Association | BIA, MedicalExpo, Medium, PubMed

Last updated: 2026-09-27

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Brainomix 360 Hyperdensity

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Transparency Registry (The Healthcare AI Institute)
Brainomix 360 Hyperdensity u2014 K260406 | Transparency Registry
Brainomix 360 Hyperdensity, developed by Brainomix Limited, received FDA 510(k) clearance on June 12, 2026, under the AI-associated product code QIH.
2026-06
FDA
List of Artificial Intelligence-Enabled Medical Devices - FDA
The FDA lists Brainomix 360 Hyperdensity by Brainomix Limited as an AI-enabled medical device in Radiology (QIH), cleared on June 11, 2026.
2026-06
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos - Innolitics
Brainomix 360 Hyperdensity was among the 86 AI/ML devices authorized by the FDA in Q2 2026, receiving 510(k) clearance on June 15, 2026.
2026-07
carbonthat
Brainomix Limited FDA Approvals and Clearances - carbonthat
Brainomix 360 Hyperdensity received 510(k) clearance from the FDA, indicating it was found substantially equivalent to a device already on the market.
2026-06
Medical AI Tools for Physicians
Brainomix: Products, FDA Status & Funding - Medical AI Tools for Physicians
Brainomix 360 Hyperdensity is described as an AI-powered neuroimaging software tool that detects and quantifies brain hyperdensities on CT scans, forming a crucial part of the Brainomix 360 Stroke platform.
2026-07
ReachMD
AI Diagnostic Benchmark Hub - ReachMD
Brainomix 360 Hyperdensity is listed in the Medical AI Diagnostic Benchmark Hub with 100.0% sensitivity and 97.6% specificity for radiology applications.
2026-06
FDA
K260406 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification document details the clearance of Brainomix 360 Hyperdensity, submitted by Brainomix Limited, with an approval date of July 19, 2026.
2026-07
Venable LLP
FDA Regulation of Post-Market Algorithm Changes: Predetermined ...
Brainomix 360 Hyperdensity (K260406) is mentioned in the context of FDA regulation of post-market algorithm changes, noting that its model weights can be retrained on expanded data without changing its clinical role.
2026-07

Videos

Product demos, reviews, and walkthroughs for Brainomix 360 Hyperdensity.

Loading videos...

View all on YouTube

Frequently Asked Questions

Brainomix 360 Hyperdensity is an AI-powered neuroimaging software tool that detects and quantifies brain hyperdensities on CT scans. It is a key component of the Brainomix 360 Stroke platform, designed to provide rapid and accurate stroke assessment. This tool helps clinicians by highlighting regions with hyperdensities and calculating ASPECTS scores, which are crucial for assessing acute ischemic stroke.
Brainomix 360 Triage Stroke, which includes hyperdensity analysis, is FDA-cleared and CE-marked, indicating its compliance with regulatory standards for medical devices and software. It has been designed, verified, and validated in compliance with 21 CFR Part 820.30 requirements, ISO 14971:2019 for risk management, and IEC 62304:2015 for software development.
Brainomix 360 can be deployed on a dedicated physical server, a virtual server, or in a secure cloud environment. Results are delivered directly to clinicians via PACS as annotated DICOM series or PDF reports, and are also accessible through a web app, mobile app, and email, integrating seamlessly with existing enterprise directories.
Key competitors in the AI-powered stroke assessment market include RapidAI, Viz.ai, and Aidoc. These platforms also offer advanced imaging software for processing CT and MRI data, providing features like large vessel occlusion detection, ischemic core and penumbra volume estimation, and workflow prioritization.
Brainomix 360 Triage Stroke is not intended for mobile diagnostic use, as images viewed on a mobile platform are compressed preview images. It does not replace the need for CTA in ischemic stroke workup, serving primarily for workflow prioritization and notification. Additionally, it is not intended to detect isolated subarachnoid hemorrhage or symmetrical bilateral MCA occlusions, and it is not a rule-out device for LVO.
Yes, Brainomix 360 Stroke has an FDA-cleared feature that enables physicians to assess ischemic core volume from universally available non-contrast CT (NCCT) images. This capability provides expert-level insights, with results demonstrating equivalency to CT perfusion (CTP) and MRI-derived core volume assessments, which is particularly beneficial in centers without ready access to advanced imaging modalities.
Clinical evidence, including a large real-world evaluation published in The Lancet Digital Health, has shown that Brainomix 360 Stroke was associated with a 100% relative increase in mechanical thrombectomy rates and a 64-minute reduction in door-in-door-out times at primary stroke units. Over 60 peer-reviewed studies validate Brainomix 360's performance and value across diverse clinical settings.

Related Tools

Zeto EEG
Zeto, Inc.
Neurology AI
Zeto EEG is an FDA-cleared, gel-free, portable EEG platform with AI-powered seizure burden and Status Epilepticus detection for critical care and outpatient monitoring.
Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
CoLumbo C-Spine
Smart Soft Healthcare AD
Clinical Decision Support & Reference
CoLumbo C-Spine is an AI-powered software that processes and analyzes cervical spine MRI exams, assisting clinicians in diagnosis and assessment.
MeRT System
Wave Neuroscience
Mental & Behavioral Health AI
MeRT (Magnetic e-Resonance Therapy) is an advanced, personalized form of TMS that uses your own brainwave data to guide treatment. It's a non-invasive, drug-free option designed to help the brain communicate more efficiently so symptoms of conditions like depression, anxiety, PTSD, TBI, autism, and more can improve.
SOMNUM
HoneyNaps
Clinical Decision Support & Reference
SOMNUM is an AI-enabled medical software tool by Honeynaps Co., Ltd. that provides comprehensive sleep analysis to aid in the diagnosis and management of sleep disorders.
DETECT-ME/CFS project
DETECT-ME/CFS project (ME/CFS Research Foundation)
Clinical Decision Support & Reference
The DETECT-ME/CFS project is developing an AI-supported clinical decision support system to improve the rapid and reliable diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

See all Neurology AI tools →

More from Brainomix

Brainomix 360 e-ASPECTS
Brainomix Limited
Neurology AI
Brainomix 360 e-ASPECTS is an FDA-cleared and CE-marked AI decision support tool that automates and standardizes the ASPECTS score and measures ischemic signs on plain CT brain scans for acute stroke assessment.
Brainomix 360 e-CTA
Brainomix Limited
Clinical Decision Support & Reference
Brainomix 360 e-CTA is an AI-powered module within the Brainomix 360 Stroke platform that automates and standardizes the assessment of collaterals and detects large vessel occlusions on CT angiography scans for acute stroke patients.
Brainomix 360 Triage ICH
Brainomix Limited
Neurology AI
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
Brainomix Limited
Neurology AI
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.

View company profile →

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

Investors who backed Brainomix 360 Hyperdensity

Funded through the company that built this tool.

AI Tool Finder
AI-powered search. Results may not be comprehensive.