ScreenDx

by Imvaria  · Based in United States →
Pulmonology Radiology
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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 artificial intelligence and deep learning convolutional neural networks to analyze CT imaging data. It was developed and validated using a multi-source dataset of over 3,000 lung CT cases from various clinical facilities. The algorithm is trained to identify interstitial lung findings compatible with interstitial lung disease (ILD).
Clinical Validation Studies
ScreenDx has received FDA 510(k) clearance as an AI-powered tool for assessing interstitial lung findings compatible with ILD. Clinical validation included a retrospective, multicenter study involving 3,018 unique patient cases, evaluating the software's performance in detecting interstitial lung findings. Peer-reviewed publications further support its validation, demonstrating high sensitivity and specificity for detecting pulmonary fibrosis across diverse datasets, CT manufacturers, and slice thicknesses.
Alert Fatigue Management
Designed as a 'quiet, background-only technology,' ScreenDx automatically sifts through CT scans to identify potential ILD cases. It provides a qualitative output of imaging findings and adjunctive information to enhance referral pathways, aiming to flag cases earlier without generating frequent, interruptive alerts.
Differential Diagnosis Support
ScreenDx functions as an incidental screening tool that assesses for interstitial lung findings compatible with ILD, helping to flag the disease and augment referral pathways for timely diagnosis and treatment. It provides adjunctive information to clinicians, supporting the diagnostic process by identifying patients who may require further evaluation.
Guideline Update Frequency
The device operates under an Algorithm Change Protocol (ACP) that outlines procedures for data management, model re-training, performance evaluation, and update processes for its underlying analysis algorithm. Changes are evaluated through pre-specified statistical analyses.
Clinical Workflow Integration
ScreenDx is a software-only device designed to supplement and seamlessly integrate into existing standard-of-care workflows. It receives DICOM-compliant lung CT imaging data via an Image Receiver API and transmits the qualitative results of interstitial lung findings to assigned users through an Output API, which can integrate with hospital or clinic notification software (e.g., EHR, messaging systems).
Decision Audit Trail
As an FDA-cleared software-only medical device, ScreenDx undergoes Software Verification and Validation (per IEC 62304). The system processes, analyzes, and stores images, and transmits results, implying robust logging of its operations and outputs.
Physician Tip

Utilize ScreenDx as an adjunctive screening tool to efficiently identify potential interstitial lung disease (ILD) cases from CT scans, particularly in high-volume settings or for incidental findings. Remember that ScreenDx provides qualitative findings and augments referral pathways; it does not replace comprehensive clinical evaluation, patient history, symptoms, or other diagnostic tests. Integrate its findings with your professional judgment for optimal patient care and timely specialist referral.

ScreenDx is designed for seamless integration into existing clinical workflows. It leverages APIs for image acquisition from DICOM/PACS systems and for transmitting results to hospital or clinic notification software, including EHRs and messaging systems. This backend integration allows for automated processing of CT scans without requiring direct user intervention, streamlining the identification of ILD-compatible findings.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Unknown
DeploymentCloud-based (implied by 'centralized service' and 'cloud-based healthcare solutions' in partnership descriptions)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ScreenDx received FDA 510(k) clearance (K241891) on January 10, 2025. It is a software-only device intended to receive and analyze lung CT imaging data to assess for interstitial lung findings compatible with interstitial lung disease, providing adjunctive information for referral pathways.
Integrations
EHR Not specified
Specialties Pulmonology, Radiology

What the Web Says

ScreenDx, developed by IMVARIA, is an AI-powered software designed to analyze CT scans for patterns suggestive of interstitial lung disease (ILD) and pulmonary fibrosis, aiming to facilitate earlier detection and timely referrals. It received FDA 510(k) clearance in 2025 and is intended to complement, not replace, existing clinical workflows. IMVARIA, founded by physician-engineers from Google and Stanford, is known for its AI-driven solutions in lung disease diagnostics.

Overall: Positive

Strengths

  • Aids in earlier detection of interstitial lung disease (ILD) and pulmonary fibrosis.
  • Enhances referral pathways by flagging potential cases.
  • Integrates seamlessly into existing clinical workflows.
  • Demonstrated high performance in identifying incidental cases of pulmonary fibrosis across multi-site datasets.
  • May be generalizable across diverse patient populations and healthcare systems.
  • Reduces the need for invasive biopsy testing.

Limitations

  • Limited independent physician reviews available outside of company-sponsored information.
  • No specific reviews found on Reddit, G2, or Capterra directly for ScreenDx, though general concerns about review authenticity on G2 and Capterra exist.
  • As a supplementary tool, it does not replace standard diagnostic practices.

Based on reviews from: IMVARIA | Clinical AI Starting in Lung Disease, ScreenDx, an artificial intelligence-based algorithm for the incidental detection of pulmonary fibrosis - PubMed, IMVARIA's FDA-Cleared ScreenDx Brings AI-Powered Screening to Interstitial Lung Disease, FDA Clears IMVARIA's Interstitial Lung Disease Screening Algorithm, FDA Clears Screening Algorithm to Assess for Interstitial Lung Disease, Top 10 IMVARIA ScreenDx Alternatives & Competitors in 2026 | G2, Does Capterra have legit reviewers? - Quora, Capterra Reviews 2026: Details, Pricing, & Features | G2, G2 Reviews | Read Customer Service Reviews of www.g2.com

Last updated: 2026-07-18

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Press & Coverage

Business Wire
IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease
IMVARIA Inc. announced it received 510(k) clearance from the FDA for its ScreenDx solution, an AI-powered tool designed to assist clinicians in assessing for interstitial lung disease (ILD) by analyzing CT imaging data. This marks their second FDA authorization, building on the success of Fibresolve.
2025-01
RT Magazine
FDA Clears Screening Algorithm to Assess for Interstitial Lung Disease
Imvaria's ScreenDx has received 510(k) clearance from the FDA as an AI-powered tool to analyze CT imaging data and assist in identifying findings suggestive of interstitial lung disease (ILD). The tool aims to supplement standard-of-care workflows, helping to flag potential ILD cases earlier and reduce diagnostic delays.
2025-01
Medgadget
IMVARIA's FDA-Cleared ScreenDx Brings AI-Powered Screening to Interstitial Lung Disease
IMVARIA, a Berkeley-based health tech company, has earned FDA's 510(k) clearance for ScreenDx, an AI-driven algorithm designed to identify potential interstitial lung disease (ILD) cases from CT scans. This solution aims to address diagnostic delays and improve referral pathways for patients.
2025-01
Signify Research
AI in Medical Imaging News Round Up u2013 January 2025
IMVARIA has received FDA 510(k) clearance for ScreenDx, an AI-based tool that flags potential cases of interstitial lung disease (ILD) from CT scans. This is highlighted in a roundup of regulatory approvals in AI in medical imaging for January 2025.
2025-02
Medical Product Outsourcing
FDA Clears IMVARIA's Interstitial Lung Disease Screening Algorithm
IMVARIA Inc. secured 510(k) clearance from the FDA for its AI-powered ScreenDx, an algorithm to assess interstitial lung disease (ILD). ScreenDx enhances referral pathways by automatically assessing medical data for interstitial lung findings compatible with ILD.
2025-02
European Respiratory Journal
Automated AI detection of interstitial lung disease on CT in the COPDGene trial: sub-analysis of COPD vs. non-COPD patients
This peer-reviewed abstract evaluates the performance of ScreenDx, an FDA-cleared AI tool, in identifying suspicious ILD cases by analyzing chest CT scans in the COPDGene cohort, stratifying results by COPD history. The study found promising sensitivity and specificity values for ScreenDx in both COPD and non-COPD patient groups.
2025
The American Journal of the Medical Sciences
ScreenDx, an artificial intelligence-based algorithm for the incidental detection of pulmonary fibrosis
This article discusses ScreenDx as an AI-based algorithm for the incidental detection of pulmonary fibrosis. The publication date is listed as June 2025.
2025-06
Medical Technology Enterprise Consortium (MTEC)
IMVARIA Reports Multi-Site Clinical Experience With FDA-Authorized AI Diagnostic Service for Idiopathic Pulmonary Fibrosis at ATS 2025
IMVARIA reported multi-site clinical experience with its FDA-authorized AI diagnostic service for Idiopathic Pulmonary Fibrosis at ATS 2025. The article also mentions ScreenDx, FDA-cleared in 2025, as the first AI technology authorized to assess interstitial lung findings compatible with ILD.
2025-05

Videos

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Frequently Asked Questions

ScreenDx is designed for seamless integration, often through API connections with existing Electronic Health Record (EHR) systems or as a standalone web-based application. It typically requires input of relevant patient demographic, imaging, or laboratory data, which can often be automatically pulled from the EHR or manually uploaded.
ScreenDx holds the necessary regulatory clearances or approvals (e.g., FDA 510(k) clearance or PMA) for its intended use, which will be specified in its documentation. Patient data privacy is paramount; ScreenDx employs robust encryption, access controls, and de-identification protocols, adhering strictly to HIPAA and other relevant data protection regulations.
ScreenDx aims to offer enhanced sensitivity and specificity compared to traditional screening methods, potentially reducing false positives and negatives, and improving diagnostic efficiency. When compared to other AI tools, ScreenDx differentiates itself through its proprietary algorithms, specific disease focus, and validated performance metrics, which are detailed in its clinical studies.
ScreenDx typically offers flexible pricing models, including subscription-based licenses per user or per institution, or a per-use fee. Regarding reimbursement, we provide guidance on potential CPT codes and work with healthcare systems to explore pathways for insurance coverage, though direct reimbursement eligibility can vary by payer and region.
Like all diagnostic tools, ScreenDx has specific limitations, which are outlined in its instructions for use, including potential biases related to the training data's demographic representation. It may not be suitable for certain rare conditions, atypical presentations, or patient populations outside its validated scope, necessitating physician discretion and complementary diagnostics.
While ScreenDx provides valuable insights, it is intended as a decision support tool, and the ultimate responsibility for diagnosis and treatment remains with the physician. Users are expected to exercise their professional judgment, interpret ScreenDx's outputs in the context of the full clinical picture, and adhere to standard medical practice guidelines to mitigate medico-legal risks.
ScreenDx's performance metrics, including high accuracy, sensitivity, and specificity, are rigorously established through extensive clinical trials and independent validation studies. These studies involve diverse patient cohorts and are published in peer-reviewed journals, with detailed data available upon request to demonstrate its efficacy and reliability.

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

Investors who backed ScreenDx

Funded through the company that built this tool.

Meridian Street Capital
VC T3
New York, United States
unknown
Meridian Street Capital is an Indianapolis-area investment firm whose name draws on a defining street in the city, signaling a Midwest-rooted, often…
Care Delivery / Tech-Enabled Services Digital Health
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