EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

by Ever Fortune. AI Co.  · Based in Taiwan →Beyond Medicine. Anytime. Anywhere. Revolutionizing healthcare with AI.
Cardiology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is an advanced software solution designed for hospitals and clinics. It leverages artificial intelligence algorithms to automatically assess the cardiothoracic ratio (CTR) from posterior-anterior (PA) chest X-ray images. The system precisely measures the maximal transverse diameter of the heart and the maximal inner transverse diameter of the thoracic cavity to calculate the CTR. This automation aims to enhance the efficiency of report generation and provide valuable assistance to physicians in their clinical decision-making and patient care processes. Ever Fortune. AI Co. specializes in AI solutions for the healthcare sector, focusing on medical big data and cloud-based biomedical platforms to aid in diagnostics and disease prediction across various medical specialties, including cardiology, oncology, and neurology.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic Cardiothoracic Ratio (CTR) assessment from chest X-rays
  • Measures maximal transverse diameter of heart and thoracic cavity
  • Utilizes artificial intelligence algorithm for analysis
  • Supports posterior-anterior (PA) chest view X-ray images
  • Outputs structured reports
  • Optimizes report generation efficiency
  • Assists physicians in clinical decision-making and patient care
  • Non-invasive software medical device
  • DICOM image analysis compatibility
  • Suitable for adults between 20-80 years of age

Use Cases

  • Screening for cardiomegaly and heart diseases
  • Assisting radiologists and physicians in efficient CTR measurement
  • Optimizing clinical workflow in cardiology and radiology departments
  • Supporting diagnostics and disease prediction in healthcare institutions

What Physicians Need to Know

Input Modality
Automated assessment of cardiothoracic ratio (CTR) from posterior-anterior (PA) chest X-ray images.
Core Function
Measures maximal transverse diameter of the heart and maximal inner transverse diameter of the thoracic cavity using an artificial intelligence algorithm to calculate the CTR.
Cardiomegaly Detection
Aids in identifying cardiomegaly, with a CTR value over 0.5 indicating its presence. The pooled AUC for cardiomegaly detection was 0.959 (95% CI 0.944u20130.975).
Efficiency
Significantly reduces variations and is almost five-fold faster than manual CTR measurement.
Heart Failure Risk Stratification
AI-based CTR measurement can help predict severe left ventricular hypertrophy (SLVH) and dilated left ventricle (DLV), serving as a risk stratification tool for cardiovascular care. Patients with baseline CTR > 0.65 had a 4.13-fold increased risk of developing SLVH/DLV in the future compared to patients with CTR u2264 0.50.
Accuracy
Observed accuracy estimates for the software were greater than 95% for identification of the imaging mode during verification testing.
Physician Tip

The EFAI iCTR system is an assistive tool for objective and efficient cardiothoracic ratio assessment from chest X-rays. Its results are not intended to be used on a stand-alone basis for clinical decision-making or to preclude comprehensive clinical assessment of any disease. Always correlate iCTR findings with patient history, physical examination, and other diagnostic tests to ensure appropriate diagnosis and management, especially when identifying potential cardiomegaly and stratifying risk for conditions like severe left ventricular hypertrophy and dilated left ventricle.

As a software system for X-ray image analysis, the EFAI iCTR is designed for use by hospitals and clinics. While specific integration details are not provided, it would typically integrate with Picture Archiving and Communication Systems (PACS) for image acquisition and Electronic Health Record (EHR) systems for reporting and clinical context, facilitating seamless incorporation into existing radiology and cardiology workflows.

Details

Category Cardiology AI
Pricing Contact for pricing
DeploymentAvailable in cloud-based versions for small- to medium-sized clinics and localized versions for larger hospitals. Can be customized for integration with existing PACS systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System received U.S. FDA 510(k) clearance (K212624) on April 4, 2022. It is classified as a Class II medical device under regulation 21 CFR 892.2050 (Medical Image Management And Processing System). The system is intended for use by hospitals and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject using an artificial intelligence algorithm. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is an AI-powered software designed for hospitals and clinics to automatically measure the cardiothoracic ratio (CTR) from posterior-anterior (PA) chest X-ray images. It aims to assist physicians and licensed practitioners in assessing cardiomegaly by providing standardized and automated CTR calculations, thereby supporting clinical workflow and potentially reducing manual workload and inter-observer variability. The system is intended for use in adults aged 20-80 years and is not meant to be a standalone diagnostic tool.

Overall: Positive

Strengths

  • Automated and standardized CTR calculation, reducing manual effort and potential for human error.
  • High accuracy in comparing iCTR-derived CTR to physician-derived CTR (0.95).
  • Aids in early detection of heart failure and cardiomegaly.
  • Can significantly shorten diagnosis time for patients.
  • Reduces observer variation and operation time.
  • FDA 510(k) cleared, indicating it meets regulatory standards for safety and effectiveness.

Limitations

  • Not intended for standalone clinical decision-making; results must be used in conjunction with clinical assessment.
  • Limited to posterior-anterior (PA) chest X-ray images.
  • Suitable only for adults between 20-80 years of age.
  • Some studies on AI-only CTR methods show higher variation compared to manual methods.
  • Radiographic cardiomegaly, even with AI, has limitations as a screening tool for congestive heart failure diagnosed by echocardiography.

Based on reviews from: FDA 510(k) K212624 (Ever Fortune.AI Co., Ltd.), FDA 510(k) K232613 (CT Cardiomegaly, predicate device comparison), FDA 510(k) K231149 (Qure.ai qXR-CTR, predicate device comparison), PMC: AI-based measurement of cardiothoracic ratio in chest X-rays and prediction of echocardiographic congestive heart failure, PMC: Cardiothoracic ratio measurement using artificial intelligence: observer and method validation studies, MDPI: Measurement of Cardiothoracic Ratio on Chest X-rays Using Artificial Intelligenceu2014A Systematic Review and Meta-Analysis, Hospitals & Health Networks: FDA Clears AI-Powered Cardiothoracic Ratio Assessment for Chest X-Rays, RecallHawk: Ever Fortune.Ai, Co., Ltd. u2014 FDA Actions, Reddit: Is Artificial Intelligence Better at Assessing Heart Health?, PMC: External Validation of an Artificial Intelligence Triaging System for Chest X-Rays: A Retrospective Independent Clinical Study

Last updated: 2026-07-18

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Press & Coverage

FDA
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (K212624) u2014 FDA 510(k)
The FDA granted 510(k) clearance to the EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System in April 2022. This software automatically assesses the cardiothoracic ratio from chest X-ray images using an AI algorithm.
2022-04
EverFortune.AI
EverFortune.AI expands its reach to Queen Elizabeth II Hospital in Malaysia
In May 2023, EverFortune.AI announced a Memorandum of Understanding with Queen Elizabeth II Hospital in Malaysia to provide seven AI software services, including a cardiothoracic ratio estimation system, to accelerate diagnostic processes.
2023-05
Diagnostic Imaging
FDA Clears AI-Powered Cardiothoracic Ratio Assessment for Chest X-Rays
Qure.ai received FDA 510(k) clearance in October 2023 for its qXR-CTR, a deep learning algorithm for automated cardiothoracic ratio measurement on chest X-rays, which can aid in detecting cardiomegaly and potentially heart failure.
2023-10
Imaging Technology News
AI-Enabled Chest X-ray for Cardiothoracic Ratio from Qure.ai Receives FDA Clearance
Qure.ai's qXR-CTR, an AI-powered chest X-ray solution for measuring cardiothoracic ratio, received FDA clearance in October 2023, marking their 12th FDA-cleared algorithm.
2023-10
Healthcare+ B2B
EVER FORTUNE AI Targets ASEAN and Western Markets with AI Medical Products, Aiming for Exponential Growth in 2025
In January 2025, EVER FORTUNE AI announced plans for significant growth in ASEAN and Western markets, having secured 43 medical device approvals worldwide, including 12 FDA clearances.
2025-01
PMC (PubMed Central)
AI-based measurement of cardiothoracic ratio in chest X-rays and prediction of echocardiographic congestive heart failure - PMC
A study published in April 2025 presents an AI model for automated cardiothoracic ratio (CTR) measurement from chest X-rays and evaluates its association with severe left ventricular hypertrophy and dilated left ventricle diagnosed by echocardiography.
2025-04
MDPI
Measurement of Cardiothoracic Ratio on Chest X-rays Using Artificial Intelligenceu2014A Systematic Review and Meta-Analysis - MDPI
A systematic review and meta-analysis from August 2024 evaluates the efficacy of AI in automating CTR determination from chest X-rays, concluding that AI can significantly shorten diagnosis time and alleviate radiologist workload.
2024-08
PubMed
Association of Artificial Intelligence Derived Cardiothoracic Ratio Assessment on Non-Cardiac Chest CT with Heart Failure and All-Cause Mortality: A Retrospective Single Center Study - PubMed
A retrospective study published in March 2026 investigates the use of an AI algorithm to measure cardiothoracic ratio on non-cardiac chest CTs as a predictor for heart failure and mortality.
2026-03

Videos

Product demos, reviews, and walkthroughs for EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System.

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Frequently Asked Questions

The EFAI iCTR system is designed for seamless integration with standard PACS (Picture Archiving and Communication Systems) and existing hospital IT infrastructure, typically through DICOM compatibility. It automatically analyzes chest X-rays to provide an iCTR assessment, which can then be viewed alongside other patient imaging data. This aims to streamline the diagnostic process without significant workflow disruption.
The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), classifying it as a Class II medical device. This clearance indicates that the device is substantially equivalent to a predicate device and can be marketed in the U.S. Physicians should also verify any relevant CE Mark certification for use in the European Economic Area, as many companies pursue CE Mark first due to less stringent evaluations.
The EFAI iCTR system aims to provide a more consistent and efficient assessment of CTR compared to manual measurements, reducing inter-observer variability and saving physician time. Studies have shown that AI-assisted methods can significantly improve agreement on inter-observer measurement and be faster to perform than manual methods. While specific comparative accuracy data would be available from the manufacturer, AI-driven tools generally enhance diagnostic accuracy and workflow efficiency.
Pricing models for AI solutions like the EFAI iCTR system often vary, commonly including subscription-based licenses, per-study fees, or enterprise-level agreements. Physicians should inquire directly with the vendor for detailed pricing structures tailored to their institution's volume and integration needs. Understanding the cost per scan or per user is essential for budget planning.
Like all AI tools, the EFAI iCTR system may have limitations related to suboptimal image quality, unusual patient anatomies, or specific pathologies not well-represented in its training data. It is crucial to understand its validated patient populations, such as being suitable for adults u2265 22 years of age, and potential for false assessments. The results are not intended to be used on a stand-alone basis for clinical decision-making.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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