Heuron ICH

by Heuron Co.  · Based in South Korea → — Because Brain Matters.
Emergency Medicine Neurology Radiology
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Regulatory Status Disclosed

Overview

Heuron ICH is an advanced artificial intelligence (AI) software designed to assist medical specialists in the rapid detection and triage of suspected intracranial hemorrhage (ICH) cases. Utilizing non-contrast computed tomography (NCCT) images, the AI solution automatically screens for and signals potential hemorrhages, including minute bleeds that may be difficult for human eyes to detect.

The primary function of Heuron ICH is to quickly identify emergency brain hemorrhages that require immediate attention, thereby prioritizing patient care and streamlining clinical workflows. The software boasts a reported sensitivity of 86% and a specificity of 88% in diagnosing intracranial hemorrhage. It provides notifications and compressed preview images without modifying the original CT images.

Heuron ICH is part of Heuron’s StroCare Suite™ and is intended to aid physicians in making faster decisions for acute stroke patients. It received U.S. Food and Drug Administration (FDA) 510(k) clearance (K233247) on May 15, 2024, marking it as the fifth solution from Heuron to earn FDA approval and the first AI-based brain disorder analysis solution from Korea for computer-assisted triage and notification devices (CADt).

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic screening and signaling of potential intracranial hemorrhage cases
  • Analyzes non-contrast CT images
  • Quickly discerns emergency brain hemorrhages needing immediate attention
  • Captures minute bleeds that may escape human detection
  • High sensitivity (86%) and specificity (88%)
  • Provides triage and priority notifications
  • Workflow improvement for medical teams
  • Assists physicians in making faster decisions

Use Cases

  • Emergency stroke care and triage
  • Prioritizing emergency patients with suspected hemorrhages
  • Aid in diagnosing central nervous system disorders
  • Assisting medical specialists in analyzing CT images for intracranial hemorrhage

What Physicians Need to Know

Stroke Detection Speed
Heuron StroCare Suite, which includes Heuron ICH, can identify urgent cases of intracranial hemorrhage within 3 minutes. A similar AI triage system for ICH has shown a mean time to notification of 3.39 minutes for suspected cases.
Brain MRI/CT Analysis
Heuron ICH specifically analyzes non-contrast CT images to automatically screen and signal potential intracranial hemorrhage cases. It is designed to quickly discern emergency brain hemorrhages, including the minutest bleeds that may escape human detection. The solution boasts a sensitivity of 86% and specificity of 88% for ICH detection.
Triage Prioritization Speed
As a computer-aided triage and notification device (CADt), Heuron ICH automatically screens and signals potential intracranial hemorrhage cases, prioritizing emergency brain hemorrhages for immediate attention. It immediately notifies critical findings to the medical team, facilitating timely interventions and improved patient outcomes. AI-based ICH notifications have been shown to significantly reduce turnaround time for newly identified hemorrhages, enabling radiologists to prioritize high-risk cases.
Mobile Notification System
Triage results are delivered via real-time notifications, allowing medical professionals to access critical information instantly from their mobile devices. The system also supports sharing high-quality images and opinions through an app chat for effective communication and rapid treatment decisions. Heuron ICH provides notifications and compressed preview images to streamline workflow and prioritize patient care.
Physician Tip

Heuron ICH assists physicians in making faster and more confident decisions by providing high sensitivity (86%) and specificity (88%) in detecting intracranial hemorrhage, including subtle lesions that might be missed by the human eye. This tool is particularly valuable in emergency patient care settings, as it optimizes the utilization of resources and helps prioritize urgent cases based on non-contrast CT scans. Immediate notification of critical findings directly to the medical team facilitates timely interventions and contributes to better patient outcomes.

Heuron ICH is designed as a computer-aided triage and notification device (CADt) that seamlessly integrates into the clinical workflow. It processes non-contrast CT images and can integrate from the CT scanner to PACS, with notifications delivered via a mobile application. Radiologists can leverage PACS-integrated AI widgets that display key images and status indicators for rapid case prioritization.

Details

Category Neurology AI
Pricing Contact for pricing — N/A
DeploymentIntegrated with hospital imaging systems (PACS/RIS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Heuron ICH received FDA 510(k) clearance (K233247) on May 15, 2024, as a computer-assisted triage and notification device (CADt) for detecting intracranial hemorrhage on non-contrast CT images. It is the fifth solution from Heuron to earn FDA clearance.
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

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Clinical Value
Ease of Use
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Support & Docs
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Press & Coverage

Medical Product Outsourcing
FDA OKs Heuron ICH AI-Powered Stroke Triage and Notification Tool
Heuron, a South Korea-based AI startup, received FDA 510(k) clearance for its Heuron ICH non-contrast CT imaging analysis solution, which automatically screens and signals potential intracranial hemorrhage cases. This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea for computer-assisted triage and notification devices (CADt).
2024-05
Diagnostic Imaging
FDA Clears AI Advance for Detecting Intracranial Hemorrhage on Non-Contrast CT
The FDA granted 510(k) clearance for Heuron ICH, an AI-enabled software that facilitates timely detection and triage of intracranial hemorrhages through interpretation of non-contrast CT scans, boasting an 86% sensitivity and 88% specificity.
2024-05
Axis Imaging News
FDA OKs Heuron's Stroke Triage and Notification Technology - Axis Imaging News
Heuron ICH, an AI technology that screens for intracranial hemorrhages using non-contrast CT images, has received U.S. FDA 510(k) clearance, making it the fifth Heuron solution to receive such approval.
2024-05
Medical Device Network
Heuron's AI solution for stroke triage receives FDA clearance - Medical Device Network
South Korean medical AI startup Heuron has obtained 510(k) clearance from the US FDA for its Heuron ICH solution, a non-contrast CT imaging analysis tool for intracranial hemorrhage, with a reported sensitivity of 86% and specificity of 88%.
2024-05
Signify Research
AI in Medical Imaging News Round Up u2013 May 2024 | Signify Research
Heuron ICH received US-FDA 510(k) clearance in May, marking Heuron's fifth AI software to receive FDA clearance and indicating the South Korean company's strategic push into the US market.
2024-06
Business Wire
Heuron Gets FDA Green Light for Stroke Triage and Notification Solution - Business Wire
Heuron announced that its non-contrast CT imaging analysis solution, Heuron ICH, has received FDA 510(k) clearance, making it the first FDA approval of an AI-based brain disorder analysis solution from Korea for computer-aided triage and notification devices (CADt).
2024-05
AVING NEWS
Heuron to Showcase 'Heuron StroCare Suiteu2122' Stroke Screening Solution at SWITCH 2024: u201cRecognized as Innovative Medical Technologyu201d < Tech & Bio < Article - AVING NEWS
Heuron will showcase its 'Heuron StroCare Suiteu2122' at SWITCH 2024, which includes Heuron ICH, a solution that automatically categorizes potential intracranial hemorrhage cases and has achieved FDA 510(k) clearance after clinical trials with Harvard's Mass General Brigham.
2024-10
PubMed Central (PMC)
Systematic review of commercial artificial intelligence tools for the detection and volume quantification in intracerebral hemorrhage - PMC
A systematic review identified Heuron ICH as one of 19 commercial AI solutions for intracerebral hemorrhage detection, noting its FDA 510(k) Class II approval in May 2024.
2025-07

Videos

Product demos, reviews, and walkthroughs for Heuron ICH.

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Frequently Asked Questions

Heuron ICH integrates seamlessly into existing workflows by analyzing non-contrast CT images to automatically screen for and flag potential intracranial hemorrhages, including minute ones. Its primary function is to prioritize emergency patients by immediately notifying the medical team of critical findings, thereby facilitating timely interventions and improving patient outcomes.
Heuron ICH has received FDA 510(k) clearance as a computer-aided triage and notification device (CADt) and holds four European CE (MDD) certifications. While specific details on Heuron's data privacy protocols were not extensively detailed, healthcare AI solutions generally adhere to regulations like HIPAA and GDPR through measures such as patient consent, data minimization, robust security safeguards, and business associate agreements.
Heuron ICH differentiates itself through its high reported sensitivity of 86% and specificity of 88% for detecting intracranial hemorrhage on non-contrast CT scans. It is specifically designed as a computer-aided triage and notification device, aiming to swiftly identify emergency brain hemorrhages and prioritize cases for rapid clinical attention.
Specific pricing models for Heuron ICH are not publicly disclosed in the available information, but AI software for healthcare typically operates on subscription-based licenses or per-study fees. Hospitals should consider factors such as patient volume, potential reduction in diagnostic turnaround times, improved patient outcomes, and the efficiency gains in workflow when evaluating its overall cost-effectiveness and return on investment.
While Heuron ICH boasts high sensitivity and specificity, it is an assistive tool for triage and notification, not a replacement for human interpretation. Physicians should exercise caution and rely heavily on their clinical judgment in complex or atypical cases, or when imaging artifacts might affect AI performance, as the AI's role is to augment, not supersede, expert medical review.
Beyond initial detection, Heuron ICH provides critical triage and priority notifications for suspected hemorrhages, which directly aids in expediting patient management. By rapidly flagging emergency cases, it supports faster decision-making and allows medical teams to intervene more quickly, potentially leading to better patient outcomes.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed Heuron ICH

Funded through the company that built this tool.

XA Network
Angel Network AI T2
Singapore, Singapore
<$250k
XA Network is a Singapore-based exclusive angel network of senior tech executives investing pre-seed and seed capital in Southeast Asia’s specialized tech…
AI/ML in Healthcare Digital Health
DigiTx Partners
VC T3
San Francisco, United States
$1M-$5M
DigiTx Partners is a healthcare and life sciences venture capital firm with a thesis spanning digital health, healthtech, and adjacent technology-enabled healthcare…
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