EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

by Ever Fortune.AI  · Based in Taiwan → — Revolutionizing healthcare with AI and big data for improved patient outcomes.
Cardiology Emergency Medicine Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer-assisted triage and notification software designed to aid in the rapid identification of acute aortic syndrome (AAS). Utilizing advanced deep learning techniques, the system automatically analyzes chest or chest-abdomen Computed Tomography Angiography (CTA) images.

Upon detecting features suggestive of Aortic Dissection (AD) or Aortic Intramural Hematoma (IMH), the system promptly alerts PACS/RIS workstations. This functionality is intended to assist hospital networks and appropriately trained medical specialists in workflow triage, enabling earlier review of high-risk studies than in standard clinical workflows. The system provides critical decision support through priority reading and alerts. It is important to note that the results are not intended for stand-alone clinical decision-making and do not rule out AAS or preclude clinical assessment of CTA cases.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Radiological computer-assisted triage and notification software
  • Utilizes deep learning algorithms for image analysis
  • Automatically analyzes chest or chest-abdomen CTA images
  • Detects features suggestive of Aortic Dissection (AD) or Aortic Intramural Hematoma (IMH)
  • Sends alerts to PACS/RIS workstations for prioritized review
  • Provides critical decision support with alerts and notifications
  • Aids in early recognition of high-risk acute clinical scenarios
  • Seamless integration with existing CT, X-ray, and PACS systems
  • Demonstrates high sensitivity and specificity in image detection
  • Validated with multi-center, multi-family data

Use Cases

  • Facilitating early recognition of high-risk acute aortic syndrome cases in emergency settings
  • Optimizing workflow triage for radiologists and medical specialists reviewing CTA scans
  • Assisting in the timely diagnosis of Aortic Dissection (AD)
  • Supporting the identification of Aortic Intramural Hematoma (IMH)
  • Enhancing patient safety through faster identification of critical conditions
  • Improving clinical outcomes by enabling earlier intervention for acute aortic syndrome

What Physicians Need to Know

Cardiac CT/MRI Analysis
The EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer-aided triage and notification software. It analyzes chest or chest-abdomen CT angiography (CTA) scans in adults aged 22 and older for automated detection and quantification of aortic dissection (AD) or aortic intramural hematoma (IMH) pathology.
AHA/ACC Guideline Alignment
The system is intended to assist hospital networks and medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection or intramural hematoma, supporting rapid diagnosis and treatment planning for acute aortic syndrome, which aligns with critical guideline recommendations for timely intervention.
Real-Time Alert Capability
EFAI AASCTA functions as a computer-aided triage and notification software, alerting PACS/RIS workstations once images with features suggestive of AD or IMH are identified. This allows radiologists to review flagged studies earlier than in standard workflows, improving the chance of early treatment.
Physician Tip

Utilize the EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM to prioritize and rapidly identify suspected cases of aortic dissection and intramural hematoma from CTA scans. This AI-powered tool can significantly accelerate the diagnostic workflow and aid in urgent treatment planning for acute aortic syndrome. Remember that the device is intended to assist in workflow triage and notification, and its results should be integrated with comprehensive clinical evaluation and other diagnostic modalities for definitive clinical decision-making.

The EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is designed to integrate seamlessly into existing clinical workflows. It alerts PACS/RIS workstations upon identifying suspected pathologies, facilitating efficient communication and data flow within hospital networks. Everfortune.AI's products generally aim for integration with existing PACS systems in hospitals.

Details

Category Cardiology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentOn-premise (local network, specialized server)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) received U.S. FDA clearance (K240291) on April 8, 2024. It is a radiological computer-aided triage and notification software indicated for use in the analysis of chest or chest-abdomen CTA in adults aged 22 and older, assisting in flagging suspected positive cases of aortic dissection (AD) or aortic intramural hematoma (IMH) pathology.

Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Radiology

What the Web Says

The EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is an AI-powered radiological computer-aided triage and notification software. It is designed to analyze chest or chest-abdomen CTA scans in adults aged 22 and older to identify suspected cases of aortic dissection (AD) or aortic intramural hematoma (IMH). The system aims to assist hospital networks and medical specialists in workflow prioritization by flagging and communicating these suspected positive cases to a PACS/workstation, allowing for earlier review by a radiologist.

Overall: Positive

Strengths

  • Aids in workflow triage and prioritization of CTA scans for acute aortic syndrome.
  • Uses an artificial intelligence algorithm to identify suspected findings of aortic dissection or intramural hematoma.
  • Provides passive notifications to PACS/workstations, integrating with existing systems.
  • Allows radiologists to review suspected cases earlier than in standard workflows.
  • FDA-authorized for image analysis/processing for cardiovascular using CT/CTA.
  • Clinical validation study conducted with a blinded, multisite approach.

Limitations

  • Not intended to direct attention to specific portions or anomalies of an image.
  • Results are not intended for stand-alone clinical decision-making.
  • Does not have a typical user interface for image interaction or manipulation.
  • Does not create reports directly; output is case-level for prioritization.
  • Poor image capture can lead to poor annotations and measurements.
  • Does not exempt users from clinical review and appropriate decision-making.

Based on reviews from: Innolitics, American College of Radiology, accessdata.fda.gov, Radiology AI Tools Directory

Last updated: 2026-07-19

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money
No press coverage or publications on file yet. Know of some? Suggest an edit →

Videos

Product demos, reviews, and walkthroughs for EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM.

View all on YouTube

Frequently Asked Questions

The EFAI CARDIOSUITE is designed for seamless integration with most standard PACS and RIS systems, typically via DICOM. It processes CTA images in the background, flagging suspected positive cases of aortic dissection or intramural hematoma and providing notifications or preliminary reports directly within the radiologist's worklist to assist in workflow triage.
The EFAI CARDIOSUITE CTA Acute Aortic Syndrome Assessment System (EFAI AASCTA) is a radiological computer-aided triage and notification software that has received FDA 510(k) clearance. It is intended to assist medical specialists in workflow triage by flagging suspected positive cases. While specific details on data privacy protocols are not extensively detailed in public FDA documents, such systems are generally expected to adhere to stringent data privacy regulations like HIPAA through robust encryption and secure infrastructure.
The EFAI CARDIOSUITE is not intended to be used on a stand-alone basis for clinical decision-making, nor is it intended to rule out Acute Aortic Syndrome (AAS) or preclude clinical assessment of CTA cases. While highly accurate, AI systems can have limitations in cases with severe motion artifacts, extensive calcification, or atypical presentations not well-represented in their training data. Physicians should always review the AI's findings in the full clinical context.
The EFAI CARDIOSUITE (EFAI AASCTA) demonstrated a sensitivity of 0.929 and specificity of 0.915 in a clinical validation study, showing substantial equivalence to a predicate device. AI-based systems like this aim to improve the speed and accuracy of AAS detection in emergency settings, potentially reducing diagnostic delays compared to traditional methods. Other AI platforms also show promising potential in identifying acute aortic dissections and related symptoms, supporting rapid, life-saving decisions.
Specific pricing models for the EFAI CARDIOSUITE are not publicly disclosed in the provided search results. Generally, AI healthcare solutions can involve various pricing structures, such as one-time capital expenditure for software licensing, annual subscription fees, or per-use charges, often tiered by study volume. Ongoing maintenance and support are typically included in subscription models or offered as separate service contracts.
Ever Fortune.AI conducted a retrospective, blinded, multisite clinical validation study for the EFAI CARDIOSUITE (EFAI AASCTA) on a dataset of 380 CTA studies. This study evaluated its performance in identifying positive findings of aortic dissection or intramural hematoma, demonstrating satisfactory results with a sensitivity of 0.929 and specificity of 0.915.
The EFAI CARDIOSUITE is explicitly described as a radiological computer-aided triage and notification software, intended to assist hospital networks and medical specialists in workflow triage. Its results are not meant to be used on a stand-alone basis for clinical decision-making, emphasizing its role as an assistive tool to highlight suspected cases for earlier review by a radiologist.

Related Tools

EchoMD AutoEF
Caption Health (formerly Bay Labs, now part of GE HealthCare)
Cardiology AI
EchoMD AutoEF is an FDA-cleared AI software that automates the selection of echocardiogram clips and calculates left ventricular ejection fraction (EF), enhancing efficiency and accuracy in cardiac assessments.
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm
Anumana, Inc.
Cardiology AI
An AI algorithm for screening cardiac amyloidosis using standard 12-lead ECGs.
DEEPVESSEL Plaque
Keya Medical Technology Co., Ltd.
Cardiology AI
An AI software platform for coronary plaque analysis and quantification from CT angiography.
WatchMate Software
Anumana, Inc.
Cardiology AI
Anumana is an AI-driven health technology company from nference, developing and delivering ECG algorithms enabling early diagnosis and intervention.
syngo.CT Coronary Cockpit
Siemens Healthineers
Cardiology AI
syngo.CT Coronary Cockpit is an AI-powered software tool by Siemens Healthineers for efficient and accurate CT coronary angiography analysis.
HeartLung AI-CVD®
HeartLung Corporation
Cardiology AI
HeartLung AI-CVD® is an FDA-cleared AI-powered quantitative imaging tool that provides automated CT-derived measurements for assessing cardiovascular and multisystem risks opportunistically.

See all Cardiology AI tools →

More from Ever Fortune. AI

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.AI Co.
Radiology & Imaging AI
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is an FDA-cleared AI software that quantifies bone age from left-hand X-rays for pediatric patients (2-16 years old), assisting radiologists in diagnosis and workflow efficiency.
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI
Radiology & Imaging AI
AI-powered computer-aided triage and notification software for assessing malpositioned endotracheal tubes on chest X-rays, designed to enhance patient safety and improve clinical outcomes through rapid alerts.
EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.AI Co.
Radiology & Imaging AI
The EFAI ChestSuite XR Pleural Effusion Assessment System is an AI-powered radiological computer-assisted triage and notification software that analyzes PA chest X-rays to identify and flag suspected pleural effusion, aiding in workflow prioritization.
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co.
Cardiology AI
The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is an AI-powered software for hospitals and clinics, designed to automatically measure the cardiothoracic ratio from chest X-ray images, enhancing diagnostic efficiency in cardiology.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
AI Tool Finder
AI-powered search. Results may not be comprehensive.