EFAI NeuroSuite CT ICH Assessment System

Emergency Medicine Neurology Radiology

Regulatory Status Disclosed

Overview

The EFAI NeuroSuite CT ICH Assessment System (EFAI ICHCT) is a radiological computer-assisted triage and notification software system developed by Ever Fortune.AI Co. It leverages advanced deep learning techniques to automatically analyze non-contrast head CT scans. The system is designed to identify features suggestive of acute intracranial hemorrhage (ICH) and then alert the Picture Archiving and Communication System (PACS) or Radiology Information System (RIS) workstation.

This AI tool aims to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with suspected acute ICH, thereby accelerating interpretation time for physicians. It can accurately detect and identify five types of ICH. The system provides a passive notification for worklist prioritization or triage, but it does not mark, highlight, or direct users’ attention to specific locations on the original non-contrast head CT images. It is compatible with major CT scanner brands such as Siemens, Philips, GE, and Canon.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatically analyzes non-contrast head CTs for acute ICH.
  • Uses deep learning techniques for detection.
  • Alerts PACS/RIS workstations for prioritization.
  • Aids in prioritizing clinical assessment of adult non-contrast head CT cases.
  • Accurately detects and identifies five types of ICH.
  • Compatible with major CT scanner brands (e.g., Siemens, Philips, GE, Canon).
  • Provides passive notification for worklist prioritization or triage.
  • Does not mark, highlight, or direct user attention to specific locations on images.

Use Cases

  • Expedited diagnosis of acute intracranial hemorrhage in emergency departments.
  • Prioritization of radiological medical images for review.
  • Triage of non-contrast head CT scans.
  • Enhancing clinical workflow for radiologists and medical professionals.

What Physicians Need to Know

Brain CT Analysis for ICH
The EFAI NeuroSuite CT ICH Assessment System is an AI-powered radiological computer-assisted triage and notification software that uses deep learning to automatically analyze non-contrast head CTs for intracranial hemorrhage (ICH). It identifies five common subtypes of ICH: intraparenchymal (IPH), intraventricular (IVH), subarachnoid (SAH), subdural (SDH), and epidural (EDH), covering both spontaneous and traumatic cases. The system has a reported ICH sensitivity of 95% and specificity of 95%. It also includes Midline Shift Quantification, which automatically calculates the degree of midline shift to aid in rapid triage decisions and surgical planning, with a sensitivity of 96% and specificity of 96%.
Triage Prioritization Speed
The system is designed to help clinical teams prioritize high-risk images and avoid missing critical cases with real-time recognition and notifications. Notifications are received from images to send in less than 2 minutes. AI-based ICH notifications have been shown to significantly reduce turnaround time for newly identified hemorrhages, demonstrating that radiologists can leverage AI alerts to prioritize high-risk cases.
Mobile Notification System
The system provides instant SMS notifications to remind doctors to prioritize suspected brain bleeding patients, aiming to speed up image reading. These notifications can help accelerate treatment and transfer decisions.
Physician Tip

This AI tool can significantly enhance the efficiency of emergency neuroimaging by rapidly detecting and classifying intracranial hemorrhages and quantifying midline shifts on non-contrast CT scans. Physicians should utilize the instant notifications to prioritize cases and expedite patient care, especially in time-critical situations where hemorrhage expansion and midline shift can rapidly deteriorate neurological status. While the AI offers high sensitivity and specificity, clinical judgment remains paramount. The system's ability to identify subtle hemorrhages, particularly subarachnoid bleeds, which are often missed, can be a valuable aid. Integrating this tool into existing PACS/RIS workflows can streamline the process, allowing radiologists to focus on interpretation rather than initial triage.

The EFAI NeuroSuite CT ICH Assessment System is compatible with all major CT brands, including SIEMENS, PHILIPS, GE, and CANON. It integrates with PACS/RIS workstations, making case-level output available for worklist prioritization or triage. The system also supports instant SMS notifications for critical findings.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

The EFAI NeuroSuite CT ICH Assessment System, developed by Ever Fortune.AI, is an FDA-cleared AI-powered software designed to assist in the rapid detection and assessment of intracranial hemorrhage (ICH) from non-contrast CT scans. It aims to improve diagnostic accuracy and expedite treatment for patients with ICH by identifying five common subtypes of hemorrhage and quantifying midline shift. The system is intended to prioritize high-risk images and provide real-time notifications to clinicians, thereby reducing the time from scan to intervention. While AI algorithms show promising diagnostic accuracy for ICH detection, further prospective studies are needed for widespread clinical implementation.

Overall: Positive

Strengths

  • Rapidly identifies brain hemorrhages and improves identification accuracy on non-contrast CT imaging.
  • Covers five clinically common subtypes of intracranial hemorrhage (IPH, IVH, SAH, SDH, EDH), including spontaneous and traumatic cases.
  • Helps clinical teams prioritize high-risk images and avoid missing critical cases with real-time recognition and notifications.
  • Automatically calculates midline shift (MLS) degree to support rapid triage decisions and surgical planning.
  • Compatible with major CT brands such as SIEMENS, PHILIPS, GE, and CANON.
  • High sensitivity (95%) and specificity (95%) for ICH detection, and high sensitivity (96%) and specificity (96%) for MLS detection.

Limitations

  • Some features may only be available as "Research Features".
  • The system provides passive notifications and does not mark, highlight, or direct users' attention to a specific location on the original non-contrast head CT.
  • The software integrates with existing PACS/workstations and does not have its own distinct graphical user interface (GUI).
  • While AI shows promise, variability and low-quality evidence limit generalizability, and further prospective studies are required before widespread clinical implementation.
  • Evidence for the system's performance is currently pending in some databases.

Based on reviews from: healthcareaiops.com, everfortuneai.com.tw, nih.gov, innolitics.com, reachmd.com, parikhradiology.com

Last updated: 2026-10-30

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Press & Coverage

genetinfo.com
EFAI NeuroSuite CT ICH Assessment System Receives US FDA Marketing Approval
Ever Fortune.AI's "EFAI NeuroSuite CT ICH Assessment System" obtained U.S. FDA 510(k) pre-market clearance (K231025) on October 5, 2023.
2023-10
The Healthcare AI Institute / Transparency Registry
EFAI NeuroSuite CT ICH Assessment System
The EFAI NeuroSuite CT ICH Assessment System is listed in The Healthcare AI Institute's Transparency Registry with FDA 510(k) clearance number K231025.
2026-08
ReachMD
Medical AI Diagnostic Benchmark: Head-to-Head Accuracy by Specialty
The EFAI NeuroSuite CT ICH Assessment System (FDA# K231025) is included in a database of FDA-cleared AI diagnostic devices, with evidence pending for its sensitivity and specificity metrics.
2026-06
NIH.gov
AI/ML-Enabled SaMDs for Stroke Triage: A Comprehensive Review of FDA-Approved Devices
The EFAI NeuroSuite CT ICH Assessment System from Ever Fortune.AI, Co., Ltd. is listed as an FDA-approved device for ICH detection with 94.7% sensitivity and 94.9% specificity, and a processing time of 34.96 seconds.
2024-11
Innolitics
Why a CLI Is Simpler to FDA Clear
The EFAI NeuroSuite CT ICH Assessment System is described as making case-level output available to a PACS/workstation for worklist prioritization or triage, providing passive notification, and not marking or highlighting specific locations on the original CT.
2025-05
Innolitics
Intracranial hemorrhage (ICH)/SDH on head CT (detection/triage)
The EFAI NeuroSuite CT ICH Assessment System's ground truth for ICH presence was determined by majority agreement among three U.S. board-certified neuroradiologists.
2025-09

Videos

Product demos, reviews, and walkthroughs for EFAI NeuroSuite CT ICH Assessment System.

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Frequently Asked Questions

The EFAI NeuroSuite CT ICH Assessment System is an AI-driven medical software tool designed to assist radiologists and emergency clinicians in analyzing diagnostic images for intracranial hemorrhage (ICH). It automatically detects five ICH subtypes (IPH, IVH, SAH, SDH, and EDH) on non-contrast CT scans with high sensitivity and specificity, providing real-time alerts within two minutes. This helps prioritize critical cases, reduce the risk of missed diagnoses, and allows radiologists to focus on interpretation rather than triage, ultimately leading to faster diagnosis and care for patients.
The EFAI NeuroSuite CT ICH Assessment System has received TFDA approval and FDA clearance. Specifically, the EFAI NeuroSuite CT ICH Assessment System (product code QAS) was cleared by the FDA on October 4, 2023.
The system demonstrates high diagnostic accuracy, with reported sensitivity and specificity rates of over 95% for detecting five intracranial hemorrhage subtypes on non-contrast CT scans. One study found the AI system achieved a sensitivity of 94.0%, specificity of 87.9%, and overall accuracy of 91.7% in detecting ICH on emergency brain CT scans.
While AI systems offer significant benefits, limitations exist. Some AI tools may have lower detection rates for specific ICH subtypes, such as subarachnoid or subdural hemorrhage, compared to overall ICH detection. Additionally, some commercial AI software may not be optimized for differentiating hemorrhage from retained contrast in patients who have undergone ischemic stroke therapy, potentially leading to false positives. It's crucial to remember that AI tools are decision support systems and their results are not intended to be used on a stand-alone basis for clinical decision-making.
The EFAI NeuroSuite integrates with existing hospital workflows, including PACS/RIS workstations, to provide automated triage, assessment, and clinical decision support. It makes case-level output available for worklist prioritization or triage. Alternatives in the market include other FDA-cleared AI tools for ICH detection such as Rapid ICH (RAPIDAI-ICH), Aidoc, Viz.ai, and Scaida BrainCT-ICH, each with varying performance characteristics.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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