Rapid Aneurysm Triage and Notification

by iSchemaView (doing business as RapidAI)  · Based in United States → — Surface silent risks—track change and guide smarter intervention.
Neurology Neurosurgery Radiology
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Regulatory Status Disclosed

Overview

The Rapid Aneurysm Triage and Notification device, developed by iSchemaView (RapidAI), is an AI-powered software designed to analyze CT angiography images of the head. It aims to detect suspected saccular aneurysms and assist hospital networks and radiologists in workflow triage by prioritizing cases for faster review. The software provides notifications and compressed preview images for informational use, supporting radiologists in triage but is not intended for diagnostic use. It leverages artificial intelligence algorithms to highlight studies with suspected saccular aneurysms, offering capabilities like converting 2D images to 3D vasculature models, calculating clinically relevant measurements, and enabling longitudinal tracking of changes over time. The platform is designed to integrate with existing hospital systems, providing access to analyzed images via PACS, email, and a mobile application.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered analysis of CT angiography images of the head
  • Detection of suspected saccular aneurysms
  • Workflow triage and prioritization of cases
  • Notifications and compressed preview images (informational use only)
  • Converts 2D images to 3D vasculature models
  • Highlights potential aneurysms and calculates measurements
  • Longitudinal tracking of aneurysm changes over time
  • High sensitivity (93%) and specificity (87%) for aneurysms 4mm and above
  • Integration with PACS, email, and mobile application for image review
  • Secure and compliant platform (HIPAA, GDPR, SOC2 Type 2)

Use Cases

  • Prioritizing CT angiography studies with suspected saccular aneurysms for faster review
  • Assisting radiologists and hospital networks in workflow triage
  • Longitudinal monitoring and assessment of aneurysm rupture risk
  • Supporting earlier intervention decisions for aneurysm management
  • Enhancing diagnostic confidence and workflow efficiency in aneurysm detection
  • Facilitating care team collaboration and communication for critical cases

What Physicians Need to Know

Evidence Base
Rapid Aneurysm Triage and Notification (ANRTN) is an FDA-cleared AI/ML image processing module, specifically a radiological computer-assisted triage and notification software device for analyzing CT images of the head. It is intended to assist in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms, analyzing CTA images in DICOM format. The tool is limited to detecting saccular aneurysms at least 4mm in diameter in adults. RapidAI's platform also incorporates 3D visualization, growth tracking, and automated measurement capabilities.
Clinical Validation Studies
The platform is clinically validated, with one extensive real-world study analyzing 11,694 consecutive CTA scans demonstrating enhanced diagnostic confidence and consistency. For aneurysms u2265 3mm, this study reported a sensitivity of 92.5% and a specificity of 96.4%. RapidAI helped identify nearly 23% more aneurysms than initially noted on original radiology reports, with these additional detections having a median size of 3.9 mm. An earlier retrospective study (2022) found Rapid Aneurysm had a sensitivity of 0.95 and a specificity of 1 for cerebral aneurysm detection. Furthermore, in evaluating longitudinal aneurysm measurements, Rapid detected 46% more clinically significant growth compared to neuroradiologists alone.
Alert Fatigue Management
The system is designed to manage alert fatigue by intelligently flagging and prioritizing studies with suspected aneurysms, thereby streamlining workflow triage. Its AI-powered triage helps filter out unnecessary noise, focusing provider attention on critical cases, which can lead to faster decision-making and reduced burnout. The system delivers specific 'triage notifications' to care teams.
Override Rate Data
Specific override rate data for Rapid Aneurysm Triage and Notification is not explicitly detailed in the provided information. The tool functions as an assistive and prioritization device, with radiologists ultimately responsible for diagnostic decisions.
Guideline Update Frequency
While a specific update frequency for the tool's internal guidelines is not stated, the FDA 510(k) clearance document for Rapid ANRTN was updated as recently as April 13, 2026, indicating ongoing regulatory oversight. The company emphasizes its 'deep clinical AI' and 'clinically validated' solutions, suggesting continuous alignment with evolving medical evidence and guidelines, such as the periodically updated AHA/ASA guidelines for aneurysmal subarachnoid hemorrhage.
Clinical Workflow Integration
Rapid Aneurysm Triage and Notification integrates within the broader Rapid Platform and is designed for seamless integration with leading Electronic Health Record (EHR) systems like Epic and Athenahealth, utilizing FHIR R4 APIs and SMART on FHIR standards. It provides anytime, anywhere access to critical patient images and results via mobile devices, desktops, or laptops, and analyzed images are available through PACS, email, and a dedicated mobile application. The system also aggregates suspected aneurysm data into a patient list for review by neurosurgery navigator teams.
Decision Audit Trail
RapidAI Insights offers a comprehensive suite of reports that provide deep insights into patient care decisions, treatment effectiveness, and the quality of Rapid platform usage. Studies have also evaluated the impact of notifications being 'viewed' or 'not viewed' by neurosurgery on follow-up rates, implying a mechanism for tracking interaction with the system's alerts.
Physician Tip

Leverage Rapid Aneurysm Triage and Notification as a powerful AI adjunct to enhance diagnostic confidence and consistency, especially for subtle or hard-to-visualize aneurysms. Utilize the automated notifications and prioritized worklists to streamline triage and ensure timely review of suspected cases. Integrate the 3D visualization and growth tracking features for comprehensive patient surveillance and treatment planning. Remember that while the tool assists in detection and prioritization, the ultimate diagnostic and treatment decisions remain with the clinician.

The Rapid Aneurysm Triage and Notification tool is built for robust integration within the Rapid Platform and is designed to connect with major EHR systems (e.g., Epic, Athenahealth) via FHIR R4 and SMART on FHIR standards. It supports multi-platform access through PACS, email, and dedicated mobile applications, facilitating seamless communication and data flow across care teams and hospital networks.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact vendor for pricing.
DeploymentHybrid, On-Premise, Cloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Rapid Aneurysm Triage and Notification device received FDA 510(k) clearance (K230074) on July 27, 2023. It is classified as a radiological computer-assisted prioritization software for lesions, intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms.
Integrations
EHR Not specified
Specialties Neurology, Neurosurgery, Radiology

What the Web Says

Rapid Aneurysm Triage and Notification by RapidAI is an AI-powered software designed to assist physicians in detecting, triaging, and monitoring intracranial aneurysms from CT angiography (CTA) and magnetic resonance angiography (MRA) scans. Studies indicate that the platform can significantly improve diagnostic accuracy and consistency, identifying a substantial number of aneurysms that might be missed by radiologists alone. It also aims to streamline clinical workflows and accelerate time to treatment, ultimately enhancing patient outcomes.

Overall: Positive

Strengths

  • Improved diagnostic accuracy and consistency, detecting more aneurysms than traditional methods.
  • Enhanced detection of subtle or hard-to-visualize intracranial anomalies.
  • Automated 3D visualization, growth tracking, and measurement capabilities provide comprehensive views.
  • Accelerates triage and transfer decisions, potentially reducing evaluation times.
  • Streamlines coordination among care teams through real-time notifications and in-app messaging.
  • Potential to reduce downstream costs associated with missed or delayed diagnoses.

Limitations

  • Some AI-enabled CDS tools, including basic triage and notification tools, may produce false positive alerts.
  • The software is intended to assist with triage and prioritization, not for diagnostic use or in lieu of full patient evaluation.
  • Limited to detecting saccular aneurysms at least 4mm in diameter in adults, though other studies suggest detection of smaller aneurysms.
  • Uncertainty regarding the impact on many patient-important outcomes, such as physical and cognitive function, mortality, and quality of life, due to limitations in available evidence.
  • Cost-effectiveness for stroke detection is currently unknown.
  • Some physicians may have differing opinions on intervention versus 'wait and monitor' for small aneurysms, even with AI assistance.

Based on reviews from: RapidAI.com, NeuroNews, accessdata.fda.gov, PMC, Slashdot, AuntMinnie, Business Wire, YouTube (Brain Aneurysm Foundation), Reddit (r/BrainAneurysm), Vascular News, Fierce Biotech, G2, HCA Healthcare, NCBI Bookshelf

Last updated: 2026-07-21

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Press & Coverage

FDA
Rapid Aneurysm Triage and Notification (K230074)
The FDA granted 510(k) clearance to iSchemaView, Inc. for its Rapid Aneurysm Triage and Notification device on July 27, 2023. This AI-powered software analyzes CT angiography images of the head to detect suspected saccular aneurysms, assisting hospital networks and radiologists in workflow triage.
2023-07
FDA.report
Radiological Computer-Assisted Prioritization Software For Lesions QFM - FDA.report
This report details the FDA clearance of iSchemaView Inc.'s Rapid Aneurysm Triage and Notification software (K230074) on July 27, 2023, categorizing it as radiological computer-assisted prioritization software for lesions (Product Code QFM). The device is intended to aid in the prioritization and triage of time-sensitive patient detection and diagnosis based on medical image analysis.
2023-07
British Journal of Radiology
Artificial intelligence in neuroradiology: a review of Food and Drug Administration-regulated algorithms
This review, published in May 2026, discusses FDA-cleared AI algorithms in neuroradiology, including aneurysm identification on CTA, and highlights how AI can reduce time to diagnosis and improve detection of subtle findings. It references Rapid Aneurysm Triage and Notification as an example of AI in cerebral aneurysm detection and management.
2026-05
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This September 2025 article on AI/ML SaMD ground truthing references iSchemaView Inc.'s Rapid Aneurysm Triage and Notification, noting that its final performance validation included 266 CTA cases with ground truth established by three experts. It discusses methodologies for establishing ground truth in AI/ML medical devices.
2025-09
X-ray Interpreter
iSchemaView | Radiology AI Companies - X-ray Interpreter
This company profile for iSchemaView (RapidAI) lists Rapid Aneurysm Triage and Notification as an FDA-cleared product, released on July 27, 2023. It describes the software as AI-powered for analyzing CT angiography images to detect suspected saccular aneurysms and prioritize cases.
2023-07

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Frequently Asked Questions

The system typically integrates with PACS and EHR via standard DICOM protocols for image ingestion and HL7 for data exchange, allowing for seamless communication. It often provides a dedicated interface within the PACS for reviewing flagged cases and can push notifications directly to physician inboxes or mobile devices, streamlining the workflow.
The system is designed to support clinical judgment and often incorporates parameters derived from established guidelines for risk stratification and follow-up recommendations. It aims to ensure timely identification and notification, which is a critical component of guideline adherence for aneurysm care, rather than replacing the guidelines themselves.
While manual review remains crucial, this system offers rapid, automated pre-screening and prioritization of studies, potentially reducing time to diagnosis and intervention for critical cases. It acts as a clinical decision support tool, augmenting human expertise by identifying subtle aneurysms that might be missed manually, especially in high-volume settings.
Pricing models often vary, ranging from per-study fees to annual subscription licenses, which can be tiered based on hospital size, imaging volume, or per user. It is important to inquire about bundled services, maintenance, and potential integration costs to understand the total cost of ownership, as these can significantly impact the overall expense.
Standalone AI systems for aneurysm detection can have high sensitivity (e.g., 91.2-97.5%) but may also present a notable false-positive rate (e.g., 13.8-16.5% per case), which could increase radiologist workload. Factors such as image quality, aneurysm size, and morphology can influence the system's accuracy, necessitating careful manual review of flagged cases.
Beyond initial detection, the system can provide risk stratification based on aneurysm characteristics and patient demographics, suggesting appropriate follow-up intervals or urgency for specialist consultation. This decision support helps standardize initial management pathways and ensures critical cases are not overlooked, supporting longitudinal patient management.
Most rapid aneurysm triage systems are specifically trained for aneurysms and may not actively flag other incidental findings. While some advanced systems might have broader capabilities, physicians should not rely solely on the aneurysm system for comprehensive incidentaloma detection and must still perform a full diagnostic review to avoid missing other pathologies.

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