Imbio PHA (4.0.0)

by Imbio  · Based in United States → — Transforming Imaging with AI to turn medical images into life-changing insights.
Cardiology Pulmonology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Imbio PHA (Pulmonary Hypertension Assessment) Software (version 4.0.0) is a cutting-edge medical image processing tool that leverages artificial intelligence to provide rapid, automated analysis of cardiothoracic CT scans. Specifically designed to work with non-gated, contrast-enhanced CT pulmonary angiogram (CTPA) images, PHA identifies and measures the maximal diameters of the heart’s right and left ventricles, the main pulmonary artery, and the ascending aorta.

The software then calculates key ratios, including the right ventricular to left ventricular diameter ratio (RV/LV) and the main pulmonary artery to aorta ratio (PA/Ao). These measurements and ratios are crucial biomarkers for assessing the severity of acute pulmonary embolism and pulmonary artery pressure. Imbio PHA integrates seamlessly into existing radiological workflows, providing annotated DICOM image series and comprehensive PDF summary reports directly into the patient study in PACS, without requiring additional user interaction.

Imbio’s solutions are developed by physicians for physicians, aiming to enhance diagnosis, improve clinical efficiencies through automation, and support data-driven, personalized patient care from screening through treatment tracking.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated measurement of right and left ventricle diameters
  • Automated measurement of main pulmonary artery and aorta diameters
  • Calculates RV/LV and PA/Ao ratios
  • Utilizes artificial intelligence algorithms for anatomical identification and measurement
  • Generates annotated DICOM images
  • Provides summary reports in PDF format
  • Integrates with native DICOM tools and workflows
  • Rapid, fully-automated assessment (typically in minutes)
  • Compatible with non-gated, contrast-enhanced CT pulmonary angiogram images
  • Supports cloud and on-premise deployment options

Use Cases

  • Assessment of potential right ventricular dilation
  • Aiding PE Response Teams (PERT)
  • Risk stratification for pulmonary and cardiopulmonary diseases
  • Assisting in diagnosis and treatment decisions for pulmonary embolism
  • Quantitative reporting of right heart strain
  • Supporting clinical assessment of CTPA cases

What Physicians Need to Know

Cardiac CT Analysis
Imbio PHA (Pulmonary Hypertension Assessment) automatically processes CT Pulmonary Angiography (CTPA) scans to measure the maximal diameters of the right and left ventricles of the heart, and the main pulmonary artery and ascending aorta.
Heart Failure Risk Prediction
The tool calculates the RV/LV ratio, a key indicator of potential right ventricular dilation, which is a significant factor in pulmonary hypertension and a predictor of short-term mortality and adverse clinical events in patients with various pulmonary vascular diseases. This indirectly aids in assessing risk related to right heart strain and potential right heart failure.
AHA/ACC Guideline Alignment
The assessment of pulmonary embolism and right ventricular dilation using CTPA, which Imbio PHA facilitates, is supported by guidelines from the American College of Radiology and the European Society of Cardiology.
Real-Time Alert Capability
Imbio PHA provides fully-automated results and summary reports, including RV/LV ratios and annotated images, delivered to PACS in as little as 4 minutes. When integrated with partner platforms like Aidoc, it can trigger targeted alerts for suspected pulmonary embolism cases.
Physician Tip

Imbio PHA provides fully-automated, quantitative measurements of RV/LV and PA/Ao ratios from CTPA scans, standardizing assessment of right ventricular dilation and pulmonary artery pressure. This information is crucial for risk stratification in acute cases, particularly pulmonary embolism, and can aid in predicting patient outcomes. Physicians should note that the software is intended to aid in assessment and not for standalone disease detection or diagnosis. Optimal performance requires adequate scan quality and contrast enhancement (LV attenuation > 100 HU), and results should be interpreted considering any comorbidities or artifacts.

Imbio PHA integrates seamlessly with Picture Archiving and Communication Systems (PACS) by automatically sending annotated images and summary reports in DICOM and PDF formats. It can be deployed via Imbio's Core Compute Platform (ICCP) in cloud or on-premise configurations, or through various partner platforms. Imbio has established partnerships with AI platforms and distributors including Blackford Analysis, Philips Healthcare, Nuance, Aidoc, Siemens Syngo.via, TeraRecon, FerrumHealth, and Flywheel. This allows for automated processing of images directly from scanners to PACS, often with the capability for real-time notifications through integrated partner solutions.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud, Enterprise (on-premise), or via partners
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Imbio PHA (4.0.0) received FDA 510(k) clearance (K241847) on August 30, 2024. It is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans, using AI to assist clinicians in evaluating cardiovascular health.

Integrations
EHR Not specified
Specialties Cardiology, Pulmonology, Radiology

What the Web Says

Imbio PHA (4.0.0) is an AI-powered medical imaging software designed for the automated analysis of CT pulmonary angiogram (CTPA) scans. It measures cardiac structures, specifically the right and left ventricles, to assess potential right ventricular dilation and aid in the diagnosis and risk stratification of pulmonary embolism and hypertension. The software integrates seamlessly into existing DICOM workflows and PACS, providing automated measurements and summary reports without requiring active user intervention.

Overall: Positive

Strengths

  • Fully automated and 'zero-click' functionality, streamlining workflow for radiologists.
  • Provides rapid, objective, and quantitative measurements from CTPA scans.
  • Aids in the diagnosis and risk stratification of pulmonary embolism and hypertension.
  • Seamless integration into existing DICOM workflows and PACS.
  • Generates annotated DICOM images and summary reports in PDF format.
  • FDA 510(k) cleared.

Limitations

  • Pricing information is not publicly disclosed.
  • Public support information is general, directing users to contact Imbio for specific manuals.
  • Serves a more specialized user base and workflow compared to some other tools.
  • Results are not intended to be used on a stand-alone basis for clinical decision-making.
  • Evidence of direct impact on patient survival and reduced healthcare utilization is not as strong as some competitors.

Based on reviews from: Physician AI Tools (Vertex AI Search), Imbio (imbio.com), 4DMedical, Health AI Register

Last updated: 2026-07-18

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Press & Coverage

PR Newswire
Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm
Imbio announced FDA 510(k) clearance for its RV/LV Analysisu2122 algorithm, a rapid, automated assessment of potential right ventricular dilation from CTPA scans. This tool provides a key patient risk indicator for pulmonary conditions like pulmonary embolism by measuring the right and left ventricles.
2021-03
Diagnostic Imaging
Imbio Captures FDA 510(k) Clearance for Cardiothoracic Imaging Algorithm
Imbio's RV/LV Analysisu2122 algorithm, cleared by the FDA, automates the measurement of heart ventricles from CTPA scans to assess right ventricular dilation. This provides clinicians with a crucial ratio for risk stratification in pulmonary conditions such as pulmonary embolism.
2021-03
PR Newswire
Aidoc and Imbio partner to provide an industry first AI solution to prioritize suspected pulmonary embolism and automatically calculate RV/LV ratio
Aidoc and Imbio partnered to create the first end-to-end AI solution for pulmonary embolism (PE), combining Aidoc's real-time notifications with Imbio's automated RV/LV ratio calculation. This aims to improve efficiency and quality of PE detection and treatment.
2020-12
Physician AI Tools
Imbio PHA (4.0.0) vs Study Watch - Physician AI Tools
This comparison highlights Imbio PHA (4.0.0) as an AI-powered software for rapid, automated analysis of CTPA scans to aid in diagnosing and risk stratifying pulmonary embolism and hypertension. It emphasizes seamless integration into clinical workflows and FDA-cleared functionalities.
unknown
Physician AI Tools
Imbio PHA (4.0.0) vs Merlin.net - Physician AI Tools
Imbio PHA (4.0.0) is presented as AI-powered medical image processing software for automated measurement of cardiac structures from CTPA scans, assisting in the diagnosis and risk stratification of pulmonary embolism and hypertension. It offers a 'zero-click' functionality for streamlined radiology workflows.
unknown
European Radiology
Automated calculation of the right ventricle to left ventricle ratio on CT for the risk stratification of patients with acute pulmonary embolism.
This peer-reviewed article discusses the automated calculation of the right ventricle to left ventricle ratio on CT scans for risk stratification in patients with acute pulmonary embolism, a core function of Imbio's PHA.
2021-01
accessdata.fda.gov
Imbio, LLC March 9, 2021 Mr. William McLain Manager, RA/QA 1015 Glenwood Avenue, Floor 4 MINNEAPOLIS MN 55405 Re: K203256
This FDA 510(k) clearance letter confirms that Imbio's RV/LV Software device, designed to measure maximal diameters of the right and left ventricles from CTPA acquisitions and report their ratio, is substantially equivalent to legally marketed predicate devices.
2021-03
Imbio (4DMedical)
Imbio to be Acquired by 4DMedical Creating Comprehensive Cardiothoracic Image Analysis Portfolio
Imbio, a provider of medical imaging analysis technologies, announced a binding agreement to be acquired by 4DMedical, aiming to create a comprehensive cardiothoracic image analysis portfolio.
2023-12

Videos

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Frequently Asked Questions

Imbio PHA (4.0.0) is a medical image processing software that utilizes artificial intelligence to automatically measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography (CTPA) scans. It provides annotated images and summary reports, including RV/LV and PA/Ao ratios, to aid clinicians in evaluating cardiovascular health and assessing potential right ventricular dilation.
The results from Imbio PHA (4.0.0) are not intended for stand-alone clinical decision-making and should not preclude a comprehensive clinical assessment of CTPA cases. Physicians must also ensure input CTPA scans meet specific acquisition parameters and are of adequate quality, as the software may not generate outputs or could produce misleading results otherwise.
Yes, Imbio states that its algorithms and operations are HIPAA compliant, having been certified by Compliancy Group, a recognized third-party certifier. Additionally, Imbio is GDPR compliant, with its practices and policies reviewed by an independent third-party consulting service.
While no clinical testing was conducted, non-clinical testing demonstrated that measurements by Imbio PHA (4.0.0) showed excellent agreement (ICC=0.94) with those made by expert radiologists. This validation included 100 contrast-enhanced CTPA datasets from multiple centers and vendors.
Alternatives to Imbio PHA (4.0.0) primarily involve manual measurement and assessment of cardiac structures by radiologists or cardiologists directly from CTPA images. While other AI solutions exist for various lung and cardiothoracic conditions, direct AI competitors specifically for automated RV/LV and PA/Ao ratio measurements from CTPA scans were not explicitly detailed in the provided information.
Imbio PHA (4.0.0) is designed to run on previously generated CTPA DICOM datasets and can be integrated as part of the radiological workflow. The software outputs annotated DICOM images and a PDF report, which can be configured to automatically send to the Picture Archiving and Communication System (PACS) for seamless access.
No, Imbio PHA (4.0.0) was designed and validated specifically on adult hearts. Therefore, its use and the interpretation of its results for pediatric patients are not validated and should be approached with caution.

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