Broncholab

by Fluidda  · Based in Belgium →World leader in functional respiratory imaging for advanced lung disease diagnosis and monitoring.
Pulmonology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Broncholab, developed by Fluidda, is an AI-powered diagnostic platform that utilizes Functional Respiratory Imaging (FRI) technology to provide detailed, regional lung function insights. It analyzes high-resolution CT scan data to deliver quantitative parameters for pulmonary tissue, assisting physicians in the diagnosis, documentation, and monitoring of various respiratory conditions.

The platform converts CT scan images into three-dimensional reconstructions of anatomical structures, such as airways and lung volumes, and employs accurate computer simulations, including Computational Fluid Dynamics (CFD), to add a unique level of functionality to the scan output. This technology provides reproducible CT values for pulmonary tissue, offering quantitative support for diagnosis and follow-up examinations.

Broncholab’s capabilities extend to 3D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low-density cluster analysis, fissure evaluation, and comprehensive reporting tools, all integrated into a dedicated workflow. It aims to provide more accurate and clinically relevant information than conventional lung function tests, enabling early and correct diagnosis and optimizing treatments for individual patients.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Functional Respiratory Imaging (FRI)
  • Quantitative HRCT analysis
  • Regional lung function visualization
  • Disease progression monitoring
  • Therapy optimization support
  • 3D segmentation and isolation of sub-compartments
  • Volumetric analysis
  • Density evaluations
  • Low density cluster analysis
  • Fissure evaluation
  • Reporting tools
  • Computational Fluid Dynamics (CFD)
  • AI/Machine Learning algorithms

Use Cases

  • Diagnosing respiratory diseases
  • Monitoring respiratory diseases
  • Optimizing treatment for individual patients
  • Early and correct diagnosis of lung conditions
  • Supporting clinical trials for new respiratory drugs
  • Assessing patient's lung function and disease progression
  • Detecting changes in lung structure (e.g., pulmonary vascular remodeling)
  • Personalized medicine for respiratory care

What Physicians Need to Know

DICOM Support & Standards
Requires CT scan images to be DICOM 3.0 compliant for input.
PACS Integration Method
Reports generated by Broncholab are saved directly onto a hospital's Picture Archiving and Communication System (PACS). CT scan data is uploaded via a secure online portal.
Reading Room Workflow Impact
Provides quantitative CT values and detailed 3D segmentation, volumetric analysis, and density evaluations, offering more accurate regional lung function insights than conventional tests. Supports diagnosis, monitoring of respiratory conditions, assessment of therapy effectiveness, and optimization of treatment plans.
AI Model Architecture (deep learning approach)
Utilizes Functional Respiratory Imaging (FRI) technology, which combines high-resolution CT scans, computational fluid dynamics, and Artificial Intelligence/machine learning for digital image processing, 3D modeling, and computational airflow simulations.
FDA Clearance Pathway
Received FDA 510(k) clearance as a Software as a Medical Device (SaMD).
Supported Modalities
Primarily uses high-resolution CT (HRCT) scans, including low-dose CT scans.
Sensitivity & Specificity Data
Fluidda's system has shown ability to identify patients with progressive idiopathic pulmonary fibrosis (IPF) versus stable disease. Performance metrics against a predicate device indicated mean differences for lobe volume, emphysema, and blood vessel density measurements were within acceptable thresholds. FRI parameters have also predicted COPD exacerbations using machine learning algorithms.
Physician Tip

Broncholab offers quantitative, regional lung function insights that go beyond conventional spirometry, enabling more accurate and early diagnosis, personalized treatment optimization, and effective monitoring of disease progression and therapy effects. It provides valuable biomarkers such as nodule and airway volume, trapped air pockets, and ventilation maps, and can predict drug particle deposition. This tool is particularly beneficial for patients with complex respiratory conditions or when standard tests may underestimate disease severity, aiding in timely adjustments to therapy and potentially reducing the need for invasive procedures.

Broncholab operates as a Software as a Medical Device (SaMD) accessible via a secure online portal for uploading CT scan data. It requires DICOM 3.0 compliant CT images as input and integrates by saving generated reports directly to the hospital's PACS.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing Not publicly available; contact vendor for details.
DeploymentSaaS (online platform/web portal)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The FDA provided market clearance to Fluidda for its Broncholab platform (K191550) in March 2020. Broncholab is a Software as Medical Device (SaMD) that provides quantitative CT values to support physicians in the diagnosis and documentation of pulmonary tissue images from CT scans.

Integrations
EHR Not specified
Specialties Pulmonology, Radiology

What the Web Says

Broncholab, developed by Fluidda, is an online platform that utilizes Functional Respiratory Imaging (FRI) to provide physicians with detailed quantitative analysis of CT scan data for diagnosing and monitoring respiratory diseases. It received FDA clearance in March 2020 and aims to offer more accurate and personalized insights into lung function compared to conventional tests like spirometry.nnThe platform is designed to assist in early and correct diagnosis, optimize treatment strategies, and has been used in clinical trials for drug development.

Overall: Positive

Strengths

  • Provides unique, detailed regional lung function insights through Functional Respiratory Imaging (FRI).
  • Offers enhanced sensitivity for diagnosing and monitoring respiratory diseases.
  • Can optimize therapy and predict drug deposition in the lungs.
  • Yields more accurate regional information than conventional lung function tests.
  • Supports physicians in diagnosis and documentation of pulmonary tissue images.
  • Potential for cost savings by quickly reviewing expensive treatments and avoiding unnecessary adverse effects.

Limitations

  • Limited to SaaS deployment, which may not suit all enterprise IT infrastructures.
  • Focuses on niche diagnostic capabilities for pulmonology rather than broad workflow needs.
  • No specific user ratings or reviews found on G2 or Capterra for Broncholab itself.
  • Initial focus on patients whose treatment options have been exhausted, not for all patients immediately.

Based on reviews from: Broncholab, QuickRad vs Broncholab - Physician AI Tools, FDA clears Fluidda's digital lung imaging platform for respiratory disease monitoring, FDA clears Fluidda respiratory imaging platform - AuntMinnie, FLUIDDA'S Magazine on Functional - OINDP News, Functional Respiratory Imaging - An innovation at just the right time - Pharma Focus Asia, FDA Clears Fluidda's Broncholab Platform for Use in Clinical Practice - PR Newswire

Last updated: 2026-07-17

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Press & Coverage

PR Newswire
FDA Clears Fluidda's Broncholab Platform for Use in Clinical Practice
The US Food and Drug Administration (FDA) granted market clearance to Fluidda for its Broncholab platform, which provides Functional Respiratory Imaging (FRI) parameters to physicians for diagnosing and monitoring respiratory diseases. This marks a significant step in bringing FRI capabilities from clinical trials into clinical practice.
2020-03
AuntMinnie
FDA clears Fluidda respiratory imaging platform
Fluidda's Broncholab, an online platform utilizing functional respiratory imaging (FRI), received clearance from the U.S. FDA to assist physicians in diagnosing and monitoring respiratory diseases. The platform combines high-resolution CT scans, computational fluid dynamics, and artificial intelligence to offer personalized medicine.
2020-03
Pharma Focus Asia
Functional Respiratory Imaging - An innovation at just the right time
Fluidda's Broncholab device, a diagnostic support tool, was cleared by the FDA, with European approval expected in Q1 2021. The technology, Functional Respiratory Imaging (FRI), aims to provide more in-depth analysis for patients whose current treatment options have been exhausted, moving beyond conventional spirometry.
2021-03
FierceBiotech
FDA clears Fluidda's digital lung imaging platform for respiratory disease monitoring
The FDA cleared Fluidda's Broncholab digital imaging platform, which offers a detailed view of lung function to diagnose respiratory diseases by visualizing factors like blood flow and predicting drug particle deposition. This platform utilizes high-resolution CT scans, digital image processing, 3D modeling, and computational airflow simulations.
2020-03
FDA
K191550 - 510(k) Premarket Notification
This FDA 510(k) Premarket Notification details the clearance of Broncholab (Fluidda, Inc.) as a Software as a Medical Device (SaMD). It provides quantitative CT values to support physicians in diagnosing and documenting pulmonary tissue abnormalities from CT scans.
2020-03
PMC
CT-Based Commercial Software Applications: Improving Patient Care Through Accurate COPD Subtyping
This peer-reviewed article highlights Fluidda's Broncholab platform as a commercial software application that utilizes functional respiratory imaging (FRI) with high-resolution CT (HRCT) to create 3D airway models for computational fluid dynamics simulations. Broncholab offers quantitative CT-based metrics for improved COPD subtyping and personalized treatment strategies.
2022-04
ResearchGate
Predicting Lung Deposition of Extrafine Inhaled Corticosteroid-Containing Fixed Combinations in Patients with Chronic Obstructive Pulmonary Disease Using Functional Respiratory Imaging: An In Silico Study
This study, published on ResearchGate, discusses the use of Fluidda's Broncholab Functional Respiratory Imaging (FRI) in predicting lung deposition of inhaled corticosteroids in COPD patients. The article highlights Broncholab's clearance by the FDA in March 2020 for clinical practice.
2026-05
Fluidda
Broncholab Offers Respiratory Solutions To Optimize Treatment Of Lung Patients
Broncholab is a platform that allows CT-scan data to be uploaded and analyzed using Functional Respiratory Imaging (FRI) technology, providing physicians with reproducible CT values for pulmonary tissue. This platform assists in diagnosing and monitoring respiratory diseases, offering detailed quantitative representations of CT images.
unknown

Videos

Product demos, reviews, and walkthroughs for Broncholab.

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Frequently Asked Questions

Broncholab integrates by allowing physicians to upload patient CT scan data to a secure online platform for analysis using Functional Respiratory Imaging (FRI) technology. It provides reproducible CT values for pulmonary tissue, offering quantitative support for diagnosis, follow-up examinations, and insights into regional lung function that traditional tests might miss.
Broncholab has received FDA 510(k) clearance in the U.S. and CE certification for use in Europe, ensuring its clinical applicability. The platform is HIPAA compliant and utilizes a secure online portal with features like data encryption, role-based access control, and audit logs to protect patient privacy.
While Broncholab offers advanced quantitative insights, it relies on CT scan data, which involves radiation exposure. Its primary focus is on analyzing existing CT images rather than providing real-time interventional guidance, and its utility is dependent on the quality and completeness of the uploaded scans.
Yes, other quantitative CT software packages exist, such as VIDA's Apollo and Imbio's Lung Density Analysis (LDA). These platforms also utilize quantitative CT techniques to assess features like airway anatomy, lung density, and vascular morphology for various respiratory conditions.
Broncholab operates on a subscription-based pricing model. Specific pricing details are not publicly available and require direct contact with the vendor, Fluidda, for a customized quote.
Functional Respiratory Imaging (FRI), the core technology of Broncholab, has been extensively used and validated in clinical trials over many years, proving its value in understanding respiratory illnesses. The platform's ability to provide more accurate regional information for diagnosis and treatment optimization has been highlighted in its FDA clearance.
Broncholab requires patient CT scan data, specifically at two lung levels: Total Lung Capacity (TLC) and Functional Residual Capacity (FRC). The CT scan images must be DICOM 3.0 compliant for successful upload and analysis on the platform.

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