ScreenDx

by IMVARIA  · Based in United States → — Advancing Clinical AI for Better Patient Lives. IMVARIA pioneers AI inference across clinical testing and imaging to generate novel physiologic signatures, creating an entirely new category of clinical intelligence: inferetics.
Pulmonology Radiology

Regulatory Status Disclosed

Overview

ScreenDx by Imvaria is an FDA-cleared, software-only clinical AI tool designed to automatically analyze chest computed tomography (CT) imaging data for findings suggestive of interstitial lung disease (ILD). It operates as an automated, background-only screening algorithm that requires no manual operation by technologists or expert users.

The tool is built for clinicians and healthcare organizations, particularly pulmonologists and radiologists, to assist in identifying potential ILD cases during routine imaging assessments. By integrating directly into existing imaging workflows, ScreenDx functions as an incidental screening and triage system. It automatically parses CT scans to flag findings compatible with ILD, helping to streamline patient referral pathways to qualified specialists for timely evaluation and treatment.

  • Automated Background Processing: Runs silently in the background of standard imaging workflows without requiring manual intervention.
  • Pattern Recognition: Utilizes machine learning to detect subtle interstitial lung findings amidst other common pulmonary conditions like COPD, emphysema, and cancer.
  • Referral Optimization: Provides adjunctive data to support earlier clinical identification and accelerate the referral pipeline to specialized pulmonary care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered analysis of CT scans for interstitial lung findings
  • Early identification of potential Interstitial Lung Disease (ILD) cases
  • Enhances referral pathways to specialists
  • Supplements standard-of-care workflows
  • Provides qualitative output based on pattern recognition
  • Seamless integration into existing clinical workflows
  • Automated operation, no expert user needed
  • Validated against various disease states (e.g., COVID, cancer, COPD/emphysema)
  • Software-only medical device
  • Accepts DICOM-compliant lung CT scan input

Use Cases

  • Screening for Interstitial Lung Disease (ILD)
  • Assisting clinicians in diverse settings (emergency rooms, lung cancer screenings, specialized clinics)
  • Reducing diagnostic delays for ILD
  • Guiding timely referrals to pulmonologists and other qualified clinicians
  • Complementing traditional diagnostic tools for lung disease assessment
  • Improving clinical decision-making for patients with suspected lung diseases

What Physicians Need to Know

Evidence Base
ScreenDx leverages AI to analyze CT scans for patterns indicative of interstitial lung findings. It is built on deep learning and convolutional neural networks, utilizing multi-modal data fusion (imaging + labs + clinical data) and CT image analysis and pattern recognition. The AI Lab, where ScreenDx operates, processes de-identified clinical cases, including imaging and lab data, and follows international standards for quality compliance (e.g., ISO 13485).
Clinical Validation Studies
ScreenDx has undergone clinical validation and external validation studies. It was tested against various disease states, including COVID, cancer, and COPD/emphysema, and validated to identify Interstitial Lung Disease (ILD) among a wide range of scans. A study investigated ScreenDx's ability to identify undiagnosed ILD cases in the COPDGene dataset, assessing its performance in detecting early or undiagnosed ILD. ScreenDx received FDA 510(k) clearance in 2025.
Alert Fatigue Management
ScreenDx is designed as a "quiet, background-only technology" that automatically sifts through CT scans to identify cases with interstitial lung findings compatible with ILD. It is intended to be supplementary to current standard-of-care workflows, providing adjunctive information as part of a referral pathway.
Differential Diagnosis Support
ScreenDx analyzes CT scans to detect patterns that may indicate interstitial lung findings, helping clinicians identify patients who require further evaluation for Interstitial Lung Disease (ILD). It is intended to augment referral pathways by flagging potential cases earlier, ensuring patients are directed to appropriate specialists.
Clinical Workflow Integration
ScreenDx is built to integrate seamlessly into existing workflows. It operates as an automated background AI algorithm that analyzes CT imaging to detect interstitial lung findings and flag cases for referral workflows. The tool is truly automated, requiring no technologist or other expert user to operate it. The results are transmitted to an assigned set of users in the hospital or clinic, such as specialists, who then review the case. IMVARIA's AI Lab operates as a centralized, cloud-based digital lab where clinicians, health systems, and clinical trialists can transmit cases for analysis, receiving reports with results in minutes.
Physician Tip

ScreenDx is an AI-powered tool designed to assist in the early identification of potential Interstitial Lung Disease (ILD) cases from CT scans. It acts as a supplementary tool to enhance referral pathways and should be used in conjunction with a patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment. ScreenDx does not replace standard diagnostic methods for lung fibrosis and is not intended to rule out or rule in lung fibrosis. The tool aims to streamline the diagnostic pathway, especially for serious diseases like ILD, by identifying patients efficiently, regardless of whether they are first seen in emergency, lung cancer screening, or specialty clinical settings.

ScreenDx is designed for seamless integration into existing clinical workflows. It utilizes an Image Receiver API for acquiring DICOM-compliant lung CT scans and an Output API for transmitting results to hospital or clinic notification software (e.g., EHR, messaging systems). IMVARIA has partnered with Viz.ai to leverage ScreenDx technology to enhance Viz.ai's suite of intelligent solutions for identifying patients who may benefit from specialized evaluation and therapy for pulmonary conditions. IMVARIA's AI Lab also offers other FDA-cleared AI solutions, such as InVision Precision Cardiac Amyloid (PCA) for cardiac amyloidosis, on a referral basis.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Unknown
DeploymentCloud-based digital lab
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Pulmonology, Radiology

What the Web Says

ScreenDx by IMVARIA is an FDA-cleared AI-powered tool designed to analyze CT scans for findings compatible with interstitial lung disease (ILD). It aims to assist clinicians in early identification and referral of patients, thereby reducing diagnostic delays for this serious condition. ScreenDx operates as a background technology, automatically sifting through CT scans without requiring expert user operation.

Overall: Positive

Strengths

  • FDA-cleared technology for assessing interstitial lung findings compatible with ILD.
  • Aids in early identification and referral of patients with potential ILD, reducing diagnostic delays.
  • Automated and operates in the background, requiring no technologist or expert user.
  • Demonstrated high performance across multi-site datasets and is generalizable across different CT manufacturers and slice thicknesses.
  • Supplements existing clinical workflows and does not replace standard diagnostic methods.
  • Validated to identify ILD among a wide range of scans, including those with COVID, cancer, and COPD/emphysema.

Limitations

  • Does not replace current standard of care methods for diagnosis of lung fibrosis.
  • Results are not intended to rule-out or rule-in lung fibrosis.
  • Intended to be used only by clinicians qualified in the care of lung disease, in conjunction with other clinical information and professional judgment.
  • Limited independent user reviews from physicians, healthcare IT, Reddit, G2, or Capterra were found in the search results.

Based on reviews from: imvaria.com, businesswire.com, nih.gov, medtechinnovator.org, xtalks.com, respiratory-therapy.com, biospace.com, g2.com, mtec-sc.org, medpath.com

Last updated: 2026-10-30

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Press & Coverage

businesswire.com
IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease
IMVARIA announced its second FDA authorization, securing 510(k) clearance for its ScreenDx solution, an AI-powered healthcare tool to assist clinicians in assessing for interstitial lung disease (ILD). ScreenDx is designed to augment referral pathways by automatically assessing for interstitial lung findings compatible with ILD, helping to flag the disease in various settings.
2025-01
xtalks.com
IMVARIA's FDA-Cleared ScreenDx Brings AI-Powered Screening to Interstitial Lung Disease
IMVARIA earned FDA 510(k) clearance for ScreenDx, an AI-powered algorithm designed to identify potential interstitial lung disease (ILD) cases by analyzing CT scans. The tool aims to enhance referral pathways and address diagnostic delays for ILD, a condition affecting approximately 650,000 people in the US.
2025-01
respiratory-therapy.com
FDA Clears Screening Algorithm to Assess for Interstitial Lung Disease
Imvaria Inc. received 510(k) clearance from the FDA for its ScreenDx solution, an AI-powered tool that analyzes CT imaging data to identify findings suggestive of interstitial lung disease (ILD). ScreenDx is intended to supplement standard-of-care workflows, aiding in earlier detection and improved referral pathways for ILD.
2025-01
theimagingwire.com
FDA Clears Imvaria AI
IMVARIA received FDA clearance for ScreenDx, an algorithm designed to detect interstitial lung disease on CT scans, making it the company's second FDA clearance following its Fibresolve algorithm. ScreenDx is intended to supplement existing workflows for ILD detection across various clinical settings.
2025-01
mpo-mag.com
IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease
IMVARIA Inc. has secured FDA 510(k) clearance for ScreenDx, an AI-powered software-only device that analyzes lung CT imaging data to detect interstitial lung findings compatible with interstitial lung disease (ILD). This marks IMVARIA's second FDA authorization, building on the success of Fibresolve.
2025-02
imvaria.com
IMVARIA Reports Multi-Site Clinical Experience with FDA-Authorized AI Diagnostic Service for Idiopathic Pulmonary Fibrosis at ATS 2025
IMVARIA reported results from multi-site clinical experiences with its diagnostic referral service for suspected Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF) at the ATS 2025 International Conference. The company also presented data on ScreenDx, an FDA-cleared AI technology for assessing interstitial lung findings compatible with ILD.
2025-05
oup.com
Characteristics of Interstitial Lung Disease Cases Accurately Identified by the AI Tool ScreenDx in the COPDGene Study
A study investigated the characteristics of patients accurately identified with Interstitial Lung Disease (ILD) by ScreenDx in the COPDGene study, noting that ScreenDx is an FDA-cleared deep learning AI tool that reviews chest CT scans to find suspected cases of undiagnosed ILD. The study found that ScreenDx successfully detected clinically significant ILD cases, with true positive cases showing differences in pulmonary function.
2025-05
viz.ai
Viz.ai Announces Strategic Partnership with IMVARIA to Enhance AI-Powered Pulmonary Disease Detection
Viz.ai announced a strategic partnership with IMVARIA Inc. to leverage IMVARIA's FDA-cleared ScreenDx™ technology. This collaboration aims to enhance Viz.ai's pulmonary portfolio and introduce new AI capabilities for assessing interstitial lung findings compatible with interstitial lung disease (ILD).
2025-11

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Frequently Asked Questions

ScreenDx is a software-only device that analyzes CT imaging data to identify findings suggestive of interstitial lung disease (ILD). It is designed to supplement standard-of-care workflows by providing adjunctive information based on pattern recognition, aiding in earlier flagging of potential ILD cases and improving referral pathways to appropriate specialists.
ScreenDx has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as an AI-powered tool to assist clinicians in assessing for interstitial lung disease (ILD). It is intended to be used only by clinicians qualified in the care of lung disease, in conjunction with the patient's clinical history, symptoms, other diagnostic tests, and the clinician's professional judgment.
ScreenDx is a supplementary tool and is not intended to replace current standard-of-care methods for diagnosing lung fibrosis. Its results are not meant to rule out or rule in lung fibrosis. Additionally, like other AI tools, it's crucial for physicians to understand that AI does not guarantee clinical accuracy and large language models can sometimes generate plausible-sounding but incorrect information.
While ScreenDx focuses on early screening and referral pathways for ILD, other AI-powered tools exist in the pulmonary space. For example, Thirona's LungQ 3.0 offers advanced thoracic CT image analysis, and Brainomix's e-Lung evaluates ILD by generating a weighted reticulovascular score.
The pricing model for ScreenDx is not publicly available. Generally, AI platforms for healthcare can have various pricing structures, including per-study fees, annual or per-site licensing, and implementation costs. For specific pricing information, it is recommended to contact Imvaria directly.
ScreenDx is designed as a quiet, background-only technology that automatically sifts through CT scans to identify interstitial lung findings compatible with ILD. It is built to integrate seamlessly into existing workflows, enhancing referral pathways by flagging potential cases earlier without requiring a technologist or other expert user to operate the tool.
ScreenDx is a deep learning convolutional neural network that analyzes CT imaging data for findings suggestive of interstitial lung disease. It has been validated against various disease states, including COVID, cancer, and COPD/emphysema, to accurately identify ILD.

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

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