CT Cardiomegaly

by Innolitics  · Based in United States → — Automated Cardiothoracic Ratio Measurement from CT Images.
Cardiology Radiology
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Regulatory Status Disclosed

Overview

CT Cardiomegaly is an automated radiological image processing software application designed to assist in opportunistic screening for cardiovascular disease. Developed by Innolitics, the tool automatically calculates both linear and area-based cardiothoracic ratios (CTR) directly from axial CT slices containing the heart.

The software utilizes a non-adaptive machine learning algorithm to identify the optimal axial slice, segment the relevant anatomy, and measure the maximal transverse diameter of the heart alongside the maximal inner transverse diameter of the thoracic cavity. By automating these measurements, the tool provides objective CTR calculations that are typically too time-consuming to perform manually during routine clinical workflows.

CT Cardiomegaly is designed for radiologists and other imaging specialists. It operates as a command-line software application that can function independently or integrate directly into existing medical devices, PACS, or teleradiology image-processing pipelines to support clinical decision-making.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic cardiothoracic ratio measurement
  • Machine learning algorithms for segmentation
  • Segmentation of heart and thoracic cavity
  • Calculates linear and area-based cardiothoracic ratios
  • Outputs PDF and JSON reports
  • Command-line software tool
  • Non-adaptive machine learning using MONAI framework
  • Validated against manual measurements by board-certified radiologists

Use Cases

  • Assisting physicians in identifying cardiomegaly
  • Providing quantitative measurements for clinical decisions
  • Opportunistic screening for cardiomegaly on routine chest and abdominal CT exams
  • Integration into other medical devices or workflows

What Physicians Need to Know

Cardiac CT/MRI Analysis
CT Cardiomegaly is a command-line software application designed to automatically calculate linear and area-based cardiothoracic ratio (CTR) from axial Chest CT images. It utilizes a non-adaptive machine learning algorithm to measure the maximal transverse diameter of the heart and the maximal inner transverse diameter of the thoracic cavity.
Heart Failure Risk Prediction
While not a direct predictor, the tool identifies cardiomegaly, which is an indicator of underlying cardiovascular disease (CVD) and is associated with various heart failure syndromes. Opportunistic screening for cardiomegaly on routine CTs aims to improve the identification and management of patients at risk for preventable CVD events.
Outputs and Performance
The software outputs linear CTR, area-based CTR, and generates PDF/JSON reports. It demonstrated a Mean Absolute Difference of 0.009 for both linear and area-based CTR (target < 0.0100), with Dice scores of 0.95 for heart segmentation and 0.98 for inner chest segmentation.
Physician Tip

CT Cardiomegaly provides an automated, objective measurement of the cardiothoracic ratio from routine chest CTs, which can serve as an opportunistic screening tool for enlarged hearts. Physicians should consider the calculated CTR as an indicator for potential underlying cardiovascular conditions. A finding of cardiomegaly warrants further clinical evaluation, which may include an echocardiogram and a comprehensive cardiac workup, to determine the etiology and guide appropriate management strategies for the patient. Early identification through this tool can facilitate timely intervention and potentially reduce the burden of cardiovascular disease.

CT Cardiomegaly is deployed as a Docker container (Ubuntu 20.04) and functions as a command-line software application. This architecture allows for flexible integration into existing healthcare IT infrastructures, such as Picture Archiving and Communication Systems (PACS), Electronic Health Record (EHR) systems, or other medical device workflows, by enabling automated processing of CT images and generation of structured reports (PDF/JSON) for seamless data flow and clinician review.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentDocker Container (Ubuntu 20.04), command-line software
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

CT Cardiomegaly (K232613) is a command-line software tool designed to automatically measure the cardiothoracic ratio from CT chest images. It received FDA 510(k) clearance on February 28, 2024, for assisting physicians in identifying cardiomegaly by providing quantitative measurements.
Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

CT Cardiomegaly by Innolitics is a command-line software application designed to automatically calculate linear and area-based cardiothoracic ratios (CTR) from chest CT images. It is intended for use by physicians and licensed practitioners in clinical settings to assist with the detection of cardiomegaly, providing a summary report with CTR values and patient information. The software does not provide a diagnosis itself, but its output is meant to inform further diagnostic work-up.

Overall: Mixed

Strengths

  • Automates cardiothoracic ratio calculation from CT images, potentially saving time and increasing efficiency.
  • Provides quantitative data (CTR values) to aid in the assessment of cardiomegaly.
  • FDA 510(k) cleared, indicating it meets regulatory standards for safety and effectiveness.
  • Designed for integration into existing medical devices or workflows as a command-line tool.
  • Performance assessment showed high accuracy in measurements compared to human readers.
  • Can be used for adults and transitional adolescents (18-21 years old).

Limitations

  • Not intended for stand-alone clinical decision-making or diagnosis.
  • As a command-line tool, it may require technical expertise for integration and operation, potentially limiting direct physician interaction without a user interface.
  • No direct user reviews from physicians, healthcare IT, tech reviewers, G2, or Capterra were found, making it difficult to assess real-world user experience.
  • Reddit discussions about cardiomegaly often highlight patient anxiety and the need for cardiologist consultation, rather than specific software reviews.

Based on reviews from: Innolitics (innolitics.com), FDA 510(k) K232613 documentation, Reddit

Last updated: 2026-07-18

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Press & Coverage

Innolitics
Analysis of 510(k) Summary: K232613 CT Cardiomegaly
This article provides a deep dive into the FDA 510(k) clearance (K232613) for CT Cardiomegaly, a command-line software application developed by Innolitics for calculating cardiothoracic ratio from CT images. It highlights the regulatory strategy of clearing a 'headless' software component to simplify human factors engineering.
2025-12
Innolitics
CT Cardiomegaly (K232613) u2014 FDA 510(k) | Innolitics
This page details the FDA 510(k) clearance for CT Cardiomegaly (K232613), outlining its intended use as a command-line software to automatically calculate linear and area-based cardiothoracic ratio from CT images. It specifies the device's regulatory classification and provides the full submission summary.
2024-02
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos
This article summarizes FDA authorizations for AI/ML devices in Q2 2026, including 84 510(k)s and 2 De Novos, with CT Cardiomegaly (K232613) listed among the cleared AI devices. It discusses trends in AI device clearances across various medical fields.
2026-07
Innolitics
First FDA-Cleared AI Agent and LLM Enabled Device Confirmed - Innolitics
This article discusses the first FDA-cleared clinical AI platform utilizing large language models and mentions CT Cardiomegaly (K232613) as another AI device cleared in 2024. It provides context on the evolving landscape of AI/ML in medical devices.
2026-06
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
This article explores the concept of 'Command Line as a Medical Device' (CLaMD) and cites CT Cardiomegaly as an example of software described as a 'command line software application' that outputs summary reports without a traditional graphical user interface.
2025-05
Innolitics
Medical Imaging AI Development - Innolitics
This page highlights Innolitics' expertise in medical imaging AI development and uses Body Check CT Cardiomegaly (K232613) as an example of a cleared AI/ML SaMD 510(k). It details their process for developing machine learning algorithms for FDA-cleared medical devices.
unknown
Physician Ai Tools
CINA CHEST vs CT Cardiomegaly - Physician Ai Tools
This comparison article contrasts CINA CHEST with CT Cardiomegaly, noting that CT Cardiomegaly (FDA clearance K232613) is designed for automated quantitative measurement of the cardiothoracic ratio from CT chest images. It highlights their different primary use cases and deployment options.
unknown
Innolitics
A note too far. When a letter to file gets a warning letter instead. - Innolitics
This article discusses an FDA warning letter regarding software updates and mentions CT Cardiomegaly (K232613) in the context of other AI/ML devices. It emphasizes the importance of proper change control for medical device software.
2026-07

Videos

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Frequently Asked Questions

AI algorithms can rapidly analyze CT images to identify and measure cardiac dimensions, potentially improving the speed and consistency of cardiomegaly detection. They can provide objective measurements that assist physicians in diagnosis and monitoring, reducing inter-observer variability and supporting more standardized reporting.
Regulatory bodies like the FDA require rigorous validation and clearance for medical AI devices, ensuring safety and efficacy before clinical use. Ethically, concerns include data privacy, algorithmic bias across diverse patient populations, transparency in AI decision-making, and maintaining physician oversight and ultimate responsibility for patient care.
AI solutions typically offer faster processing times and more consistent, objective measurements compared to manual methods, which can be time-consuming and prone to inter-reader variability. While AI can significantly improve efficiency and standardization, manual review by a trained radiologist remains crucial for complex cases and clinical correlation.
Pricing models vary, often including subscription fees, per-study charges, or perpetual licenses, influenced by factors like hospital size, scan volume, and the specific features offered. Initial setup costs, integration expenses, and ongoing maintenance or support fees should also be considered when evaluating the total cost of ownership.
Limitations can include challenges with atypical cardiac anatomies, artifacts from poor image quality, or the need for extensive training data to generalize across diverse patient populations and imaging protocols. AI may also struggle with differentiating true cardiomegaly from other conditions without additional clinical context or advanced imaging sequences.
Integration is a critical concern, with most AI solutions designed to be DICOM-compliant and integrate via standard APIs or middleware to ensure smooth workflow. However, the actual ease of integration can vary significantly depending on the specific vendor, the hospital's existing IT infrastructure, and the need for customized workflows or data mapping.
Physicians should expect robust clinical validation studies demonstrating high sensitivity, specificity, and accuracy across diverse patient cohorts, ideally published in peer-reviewed journals. Real-world performance data, including post-market surveillance, ongoing algorithm updates, and evidence of generalizability, are also important indicators of reliability and clinical utility.

Compare CT Cardiomegaly

VS
CT Cardiomegaly vs EchoNext
Cardiology AI Adjacent · 65/100
Both tools are FDA-cleared AI solutions in cardiology, but they differ in their primary focus and input data. CT Cardiomegaly analyzes CT chest images to measure cardiothoracic ratio…
VS
CT Cardiomegaly vs PMcardio
Cardiology AI Adjacent · 65/100
Both tools are AI-powered cardiology solutions, but they operate on different diagnostic modalities. Tool A, CT Cardiomegaly, focuses on analyzing CT chest images for cardiothoracic ratio measurement and…
VS
CT Cardiomegaly vs V7 Diagnostic Ultrasound System
Cardiology AI Adjacent · 65/100
Tool A, Innolitics' CT Cardiomegaly, is a specialized software for automated cardiothoracic ratio measurement from CT chest images, focusing on cardiomegaly detection. Tool B, the Samsung V7 Diagnostic…
VS
Lung AI vs CT Cardiomegaly
Cardiology AI Adjacent · 65/100
Tool A is a handheld ultrasound platform with integrated AI for real-time cardiac and lung scanning, enabling immediate clinical decisions at the point of care. In contrast, Tool…

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