Annalise Enterprise CTB Triage-OH

by Annalise-AI Pty  · Based in Australia → — Comprehensive AI clinical decision support solutions, empowering clinicians to make accurate, faster decisions in medical imaging.
Emergency Medicine Neurology Radiology
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Regulatory Status Disclosed

Overview

Annalise Enterprise CTB Triage-OH is a medical device software application that utilizes an artificial intelligence (AI) algorithm to identify suspected obstructive hydrocephalus (OH) findings in non-contrast computed tomography (NCCT) brain scans. This software workflow tool is designed to aid in the triage and prioritization of radiological medical images, making study-level output available to an order and imaging management system for worklist prioritization or triage. The device employs a convolutional neural network trained using deep-learning techniques on extensive datasets, including over 200,000 CT brain imaging studies, annotated by qualified radiologists. It provides both passive and active notifications for suspected OHCP cases, enabling clinicians to review critical studies earlier in the workflow without decreasing the existing priority of other studies. Annalise Enterprise CTB Triage-OH is intended for adjunctive use by trained clinicians qualified to interpret brain CT studies, enhancing diagnostic accuracy and efficiency in radiology and emergency care settings.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered obstructive hydrocephalus detection
  • Non-contrast brain CT analysis
  • Worklist prioritization and triage
  • Passive and active notifications
  • Convolutional neural network algorithm
  • Deep learning techniques
  • Compatible with PACS/RIS
  • Aids in diagnostic accuracy
  • Enhances workflow efficiency
  • Supports rapid clinical decision-making

Use Cases

  • Triage and prioritization of non-contrast brain CT studies
  • Early detection of obstructive hydrocephalus
  • Improving diagnostic accuracy in radiology departments
  • Accelerating critical interventions in emergency care
  • Optimizing radiology workflow
  • Providing a 'second set of eyes' for radiologists

What Physicians Need to Know

Brain CT Analysis
Utilizes an AI algorithm (convolutional neural network with deep learning) trained on over 200,000 CT head cases to analyze non-contrast CT (NCCT) brain scans. It identifies up to 130 findings, including critical, time-sensitive conditions such as obstructive hydrocephalus, acute subdural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, intraventricular hemorrhage, mass effect, and vasogenic edema. The device provides study-level output and is not intended to direct attention to specific image portions.
Stroke Detection Speed
Identifies suspicious findings of obstructive hydrocephalus within minutes of assessing non-contrast brain CT scans. The broader Annalise CT Brain (CTB) solution detects up to 130 findings in under 90 seconds. A related device, Annalise Enterprise CTB Triage Trauma, demonstrated a triage turnaround time of 81.6 seconds.
Triage Prioritization Speed
Expedites workflow by making study-level output available to order and imaging management systems for worklist prioritization. It actively notifies clinical teams (neurologists, neuroradiologists, radiologists, emergency physicians) of suspected findings to facilitate faster care coordination.
Mobile Notification System
Enables both passive and active notifications for suspected cases, integrating with imaging and order management systems for worklist prioritization and direct communication to the clinical team.
Physician Tip

Annalise Enterprise CTB Triage-OH is an adjunctive AI tool designed to rapidly identify and prioritize critical findings like obstructive hydrocephalus and various hemorrhages on non-contrast head CT scans. It is intended to enhance workflow efficiency and accelerate care coordination by flagging urgent cases for earlier review, but it does not replace the trained clinician's interpretation or clinical decision-making. Physicians should always review the AI output concurrently with the original images and all other relevant clinical information.

The system is designed to integrate seamlessly with existing image and order management systems, such as Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS). It makes study-level output available to these systems for worklist prioritization and can send active notifications to clinical teams.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing
  • Subscription-based model; Annual cost of $180,000 per hospital (as per FY 2025 IPPS final rule for NTAP)
DeploymentSoftware workflow tool, integrates with image and order management systems (PACS/RIS).
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Annalise Enterprise CTB Triage-OH received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on August 15, 2023, for the triage and notification of obstructive hydrocephalus on non-contrast brain CT scans. It also received FDA Breakthrough Device Designation.
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

Annalise Enterprise CTB Triage-OH is an AI-powered tool designed to assist radiologists in identifying suspected intracranial hemorrhage (ICH) on CT brain scans. It aims to improve workflow efficiency and reduce time to diagnosis for critical cases by triaging studies and highlighting potential bleeds, allowing for faster review by a radiologist. The system is intended to be a decision support tool, not a replacement for human interpretation.

Overall: Positive

Strengths

  • Accelerates identification of critical cases like intracranial hemorrhage.
  • Improves workflow efficiency for radiologists by triaging studies.
  • Potentially reduces time to diagnosis for urgent conditions.
  • Aids in prioritizing radiologist workload.
  • Designed to be user-friendly and integrate into existing PACS.
  • Can enhance patient outcomes through earlier intervention.

Limitations

  • Relies on human oversight; not fully autonomous.
  • Potential for 'alert fatigue' if too many false positives occur.
  • Integration challenges with diverse hospital IT infrastructures.
  • Cost of implementation and ongoing maintenance.
  • Requires validation and trust-building within clinical settings.
  • Limited information available on long-term clinical impact studies.

Based on reviews from: Annalise.ai official website, Healthcare IT News, Radiology Today, AuntMinnie.com, PubMed (for related research on AI in radiology), LinkedIn (discussions among healthcare professionals)

Last updated: 2026-07-17

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Support & Docs
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Press & Coverage

AuntMinnie
CMS approves head NCCT AI product for new technology add-on payments - AuntMinnie
Annalise Enterprise CTB Triage-OH received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2023 as a breakthrough device and is approved for a new technology add-on payment (NTAP) of $241.39 for FY 2025. This AI software aids in the triage and prioritization of studies with features suggestive of obstructive hydrocephalus (OH) in noncontrast CT (NCCT) brain scans.
2024-08
BEUDAMED
Annalise Enterprise CTB Triage-OH - BEUDAMED
Annalise Enterprise CTB Triage-OH received FDA 510(k) clearance (K231094) on August 15, 2023, classifying it as a Class 2 medical device under regulation number 892.2080.
2023-08
FDA
510(k) Premarket Notification - FDA
This FDA document details the 510(k) Premarket Notification for Annalise Enterprise CTB Triage-OH, submitted by Annalise-Ai Pty, Ltd. It confirms the device's classification under regulation number 892.2080.
2026-06
X-ray Interpreter
Annalise Enterprise CTB Triage Trauma | FDA Radiology AI Device - X-ray Interpreter
Annalise Enterprise CTB Triage Trauma, an AI-based software tool, analyzes non-contrast brain CT scans to detect signs of vasogenic edema and mass effect, helping prioritize cases for earlier review. The device uses a convolutional neural network AI algorithm trained with deep learning and interfaces with PACS/RIS systems.
2023-09
MedDeviceGuide
FDA Breakthrough Device Designation: Program Guide for 2026 - MedDeviceGuide
Annalise Enterprise CTB Triage-OH is listed as an AI-based triage software for CT brain imaging that has received FDA Breakthrough Device Designation. This program expedites the development and review of devices that provide more effective treatment or diagnosis for life-threatening or debilitating conditions.
2026-04
Healthcare Financial Management Association | HFMA
Medicare Hospital Inpatient Operating and Capital Payment Rules - Healthcare Financial Management Association | HFMA
The Centers for Medicare & Medicaid Services (CMS) released its proposed rule for FY 2026, which includes policies and rates for Medicare's inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system. Annalise Enterprise CTB Triage-OH is listed with an effective date for new technology add-on payments starting October 1, 2024, and ending October 10, 2026, with a payment of $241.39.
2025-04
ResearchGate
Evaluation of an arti cial intelligence model for identi cation of obstructive hydrocephalus on computed tomography of the head - ResearchGate
This study evaluated the accuracy of an AI model (Annalise Enterprise CTB) in identifying obstructive hydrocephalus on non-contrast head CT scans. The research was funded by Annalise-AI, and the model demonstrated effective triage within a clinician's queue based on high sensitivity and specificity.
2024-12
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
Annalise Enterprise CTB Triage-OH is noted for making study-level output available to an order and imaging management system for worklist prioritization or triage, integrating directly into existing systems rather than having its own user interface. This approach is contrasted with predicate devices that might direct output to a separate desktop application.
2025-05

Videos

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Frequently Asked Questions

Annalise Enterprise CTB Triage-OH integrates with existing PACS and RIS to identify suspected obstructive hydrocephalus (OH) on non-contrast CT brain scans. Its primary function is to triage and prioritize these cases within the radiology worklist, and send active notifications to the clinical team, aiming to expedite care coordination.
Yes, Annalise Enterprise CTB Triage-OH received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2023 as a Class II medical device and was granted Breakthrough Device Designation. As a medical device software operating within the medical care environment, it is designed to adhere to relevant data privacy regulations, including HIPAA.
This AI tool is intended for adjunctive use by trained clinicians and is not a standalone diagnostic tool; its results should not be used to direct attention to specific image portions or preclude full clinical assessment. Furthermore, it is indicated for patients 22 years or older.
Hospitals typically acquire Annalise Enterprise CTB Triage-OH on a subscription-based model, with an annual cost of approximately $180,000 per hospital. It is eligible for a Medicare New Technology Add-on Payment (NTAP) of about $241.39 per case for Medicare inpatients, recognizing its substantial clinical improvement.
While other computer-assisted triage devices exist for general intracranial hemorrhage detection, Annalise Enterprise CTB Triage-OH is specifically designed for obstructive hydrocephalus. It is noted as the only radiology AI triage device in the US eligible for separate, additional Medicare hospital payment for this specific indication.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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