Brainomix 360 Triage ICH
Overview
Brainomix 360 Triage ICH is an FDA-cleared, AI-powered notification tool designed to provide real-time alerts of suspected intracranial hemorrhage (ICH) to clinicians. The software assesses non-contrast CT (NCCT) scans of the brain from adult patients in acute settings, typically within 24 hours of symptom onset, and generates a priority notification when ICH is detected. This tool is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings to specialists in parallel to standard image interpretation. It supports treatment and transfer decisions for stroke patients, helping to optimize workflow across stroke networks and facilitate faster care. The software also offers basic image viewing through multiple formats and delivers notifications directly to clinicians’ smartphones via a mobile application.
Brainomix 360 Triage ICH is a standalone software device that utilizes machine learning algorithms and advanced imaging analytics. It is compliant with the DICOM standard and can run on off-the-shelf physical or virtual servers. While it provides critical information for triage, it is not intended for diagnostic use beyond notification, and clinicians are responsible for viewing non-compressed images on a diagnostic viewer for final decisions.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time alerts for suspected intracranial hemorrhage (ICH)
- AI-powered analysis of non-contrast CT (NCCT) scans
- Smartphone notifications for clinicians
- Basic image viewing through multiple formats
- Optimizes workflow across stroke networks
- Facilitates faster treatment and transfer decisions
- DICOM compliant software
- Runs on physical or virtual servers
- Assists in triage of acute stroke patients
- Provides priority notifications
Use Cases
- Triage of patients with suspected intracranial hemorrhage (ICH)
- Aiding in rapid treatment and transfer decisions for stroke patients
- Excluding certain treatments (e.g., thrombolysis, thrombectomy) based on ICH presence
- Optimizing workflow in stroke networks
- Supporting both specialist and non-specialist centers in stroke care
- Improving patient outcomes by reducing treatment delays
What Physicians Need to Know
Brainomix 360 Triage ICH is an FDA-cleared notification tool that significantly aids in the rapid identification and triage of intracranial hemorrhage. It should be used as a decision support tool in conjunction with a physician's professional judgment and standard of care image interpretation, not as a primary diagnostic device. The real-time alerts and mobile access can help expedite critical treatment and transfer decisions for stroke patients.
The Brainomix 360 platform, including Triage ICH, is DICOM compliant and operates on an off-the-shelf physical or virtual server. It integrates with existing hospital networks to provide notifications via a web user interface and dedicated mobile applications (Android and iOS), and can send pseudonymized result images via email.
Details
| Category | Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI |
| Pricing | Contact vendor |
| Deployment | On-premise or cloud-based server |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Brainomix 360 Triage ICH received FDA clearance (K231195) on July 27, 2023. It is cleared as a notification-only, parallel workflow tool to identify and communicate images suggestive of intracranial hemorrhage on non-contrast CT brain images to specialists. |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Neurology, Radiology |
What the Web Says
Brainomix 360 Triage ICH is an FDA-cleared AI-powered notification tool designed to provide real-time alerts of suspected intracranial hemorrhage (ICH) to clinicians, directly to their smartphones. It assesses non-contrast CT scans and flags the presence of ICH, aiding in rapid treatment and transfer decisions for stroke patients. The software is part of the broader Brainomix 360 Stroke platform, which has demonstrated significant improvements in stroke care workflows and patient outcomes.
Overall: PositiveStrengths
- High sensitivity (93%) and specificity (94%) for ICH detection.
- Provides real-time alerts to clinicians' smartphones, facilitating faster treatment decisions.
- Aids in optimizing workflow across stroke networks.
- Can help differentiate strokes from 'stroke mimics'.
- Associated with increased rates of mechanical thrombectomy and reduced delays in patient triage and transfer.
- Validated in real-world studies with a large patient cohort.
Limitations
- Mobile app images are for informational purposes only and not for diagnostic use.
- Not intended to detect isolated subarachnoid hemorrhage or symmetrical bilateral MCA occlusions.
- Not intended for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations, or venous thrombosis.
- False positives for hemorrhage detection can be caused by areas of calcification.
- Compared to other AI tools, Brainomix literature is less focused on perfusion analysis (Rapid CTP) and LVO detection.
- Pricing information is not readily available and requires direct contact with sales.
Based on reviews from: NeuroNews, Brainomix, accessdata.fda.gov, Xtalks, Google Play, MDPI, PR Newswire, Diagnostic and Interventional Cardiology, AuntMinnieEurope, G2, Medical Device and Diagnostic industry, Reddit
Last updated: 2026-07-18
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