Hyper Insight – ICH

by SK Inc.  · Based in South Korea → — AI-powered triage and notification for suspected intracranial hemorrhage.
Emergency Medicine Neurology Radiology
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Regulatory Status Disclosed

Overview

Hyper Insight – ICH is a software as a medical device (SaMD) designed as a notification-only workflow tool for trained clinicians. It leverages deep learning-based AI algorithms to analyze non-contrast brain CT images. The primary function is to identify patients with suspected intracranial hemorrhage (ICH) and promptly share these findings with medical specialists. This tool operates in parallel with standard patient care workflow, aiming to assist in the rapid triage and prioritization of cases. It is crucial to note that the identification of suspected intracranial hemorrhage by Hyper Insight – ICH is for notification purposes only and is not intended for diagnostic purposes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered detection of suspected intracranial hemorrhage (ICH)
  • Analysis of non-contrast brain CT images
  • Notification system for medical specialists
  • Deep learning algorithms for image analysis
  • Workflow tool for triage and prioritization
  • Integration with third-party worklist applications
  • Mobile app for informational previews and notifications

Use Cases

  • Rapid triage of brain CT images for suspected ICH
  • Prioritization of cases requiring urgent review by medical specialists
  • Assisting clinicians in identifying patients with suspected ICH for faster intervention
  • Streamlining radiology workflow for critical findings

What Physicians Need to Know

Stroke Detection Speed
Delivers AI-supported findings for acute Intracerebral Hemorrhage (ICH) on non-contrast CT scans within seconds, facilitating rapid identification and review of time-critical cases.
Brain MRI/CT Analysis
Specializes in analyzing non-contrast head CT images to automatically detect acute intracranial hemorrhage (ICH). The software provides a binary prediction (presence or absence of ICH) and highlights suspicious regions.
Triage Prioritization Speed
Functions as a notification-only workflow tool that automatically highlights and sorts urgent ICH cases by severity, enabling faster time-to-review and prioritization for medical specialists.
Mobile Notification System
Offers a mobile application (available on iOS) for notifications and previews of images, supporting hospital-based workflows. Images viewed via the app are for informational purposes and notifications only, not for final diagnostic use.
Physician Tip

Hyper Insight - ICH is designed as a notification and workflow prioritization tool, not for definitive diagnosis. Physicians should utilize its rapid detection capabilities on non-contrast CT to quickly triage suspected ICH cases and prioritize their review. Always confirm findings with a diagnostic viewer and integrate the AI insights with comprehensive patient assessment. The mobile app can be valuable for immediate alerts and preliminary image review, but final diagnostic decisions must be made by a trained clinician reviewing the full diagnostic images.

The software is designed for seamless integration with existing hospital imaging systems (PACS). It requires integration with a third-party worklist application to receive analysis requests and DICOM images, and to return ICH findings to alert radiologists within their standard workflow.

Details

Category Neurology AI
Pricing Unknown
DeploymentSoftware as a Medical Device (SaMD), requiring integration with a third-party worklist application.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Hyper Insight - ICH received FDA 510(k) clearance (K240353) on July 1, 2024. It is classified as Radiological Computer-Assisted Triage And Notification Software (Product Code QAS). The device is for notification purposes only and should not be used for final diagnosis.
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

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Press & Coverage

CARPL.ai
CARPL partners with Purple AI to Expand Access to FDA-Cleared AI for Intracranial Hemorrhage Detection
CARPL.ai and PurpleAI announced a strategic partnership to integrate PurpleAI's FDA-cleared Hyper Insight - ICHu2122 solution into the CARPL platform, aiming to accelerate the adoption of AI-powered tools for intracranial hemorrhage detection in emergency settings.
2025-06
accessdata.fda.gov
K240353 - Hannah Taggart - accessdata.fda.gov
This FDA 510(k) premarket notification details the Hyper Insight - ICH device, a software as a medical device (SaMD) that uses deep learning to detect suspected intracranial hemorrhage on non-contrast CT images for notification and triage purposes.
2024-07
BDMT Global
2026 TOP 40 Global Innovations + 10 Technologies to Watch - BDMT Global
Hyper Insightu2013ICH, an FDA-cleared AI software, is recognized among the 2026 Top 40 Global Innovations for its ability to triage suspected brain hemorrhage in seconds on NCCT scans with 99% accuracy, acting as a real-time AI safety net.
2026
American College of Radiology
AI Central Market Updates for September 12, 2024 - American College of Radiology
The American College of Radiology's AI Central updated its directory with Hyper Insight - ICH, developed by SK Inc., highlighting it as a notification-only workflow tool that uses deep learning to identify suspected intracranial hemorrhage on brain CT images.
2024-09
PMC (PubMed Central)
Systematic review of commercial artificial intelligence tools for the detection and volume quantification in intracerebral hemorrhage - PMC
This systematic review, published in July 2025, includes Hyper Insightu2014ICH (SK Inc.) among 19 identified AI solutions for intracerebral hemorrhage detection, noting its FDA 510(k) Class II clearance in January 2024 for ICH detection and triage function.
2025-07
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - MDPI
A December 2025 publication lists Hyper Insightu2014ICH (K240353) as one of the 168 ML-enabled Class II devices authorized by the FDA in 2024, cleared via the 510(k) pathway for intracranial hemorrhage triage and notification, with reported sensitivity of 95.5% and specificity of 98.5%.
2025-12
The Imaging Wire
RadGPT Simplifies Reports, CTC Vs. DNA Test, and Vendor Earnings - The Imaging Wire
The Imaging Wire reported in June 2025 that CARPL.ai added PurpleAI's Hyper Insight u2013 ICH, an FDA 510(k) cleared AI algorithm, to its platform for detecting intracranial hemorrhage on non-contrast head CT scans, enabling triage and notification of suspicious findings.
2025-06
Google Play
Hyper Insight - ICH - Apps on Google Play
The Hyper Insight - ICH mobile application, developed by PurpleAI (SK Inc.), supports hospital-based workflows with in-app alerts and chat for real-time communication and opinion sharing among doctors, with its latest update on January 23, 2026, improving stability and features.
2026-01

Videos

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Frequently Asked Questions

Hyper Insight - ICH is a notification-only workflow tool that uses deep learning AI to analyze non-contrast brain CT images for suspected intracranial hemorrhage. It identifies these images and shares findings with medical specialists, including neurologists, in parallel with standard patient care workflow. This aims to expedite the identification and triage of critical cases.
Hyper Insight - ICH has received FDA 510(k) Class II clearance (K240353) for its intended use as a radiological computer-assisted triage and notification software. As an FDA-cleared medical device, it adheres to regulatory requirements for safety and effectiveness in the U.S. market.
It is crucial to remember that Hyper Insight - ICH is a notification-only tool and not intended for diagnostic purposes. It should not replace a full patient assessment or be solely relied upon to make or confirm a diagnosis, as the medical specialist remains responsible for definitive image interpretation.
Other FDA-cleared AI tools for intracranial hemorrhage detection that neurologists might consider include Viz.ai ICH and Aidoc. These platforms also utilize AI to assist in the rapid identification and triage of ICH cases, offering similar functionalities for workflow enhancement.
Specific pricing details for Hyper Insight - ICH are not publicly disclosed in the available information. Typically, such medical AI software solutions are offered through institutional licensing or subscription models, with costs often varying based on factors like hospital size, usage volume, and integration requirements.
As an FDA-cleared medical device, Hyper Insight - ICH is expected to comply with stringent healthcare data privacy regulations, such as HIPAA, to protect patient health information. The software is designed to integrate with third-party worklist applications to securely receive and process DICOM images for analysis and notification.

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