Products

Fibresolve
IMVARIA
Clinical Decision Support & Reference
Fibresolve is the first FDA-authorized AI diagnostic service in idiopathic pulmonary fibrosis (IPF) and interstitial lung disease (ILD), using non-invasive analysis to help drive diagnosis.
ScreenDx
IMVARIA
Clinical Decision Support & Reference
ScreenDx is a first-of-its-kind, FDA-cleared AI technology from Imvaria that automatically assesses CT scans for interstitial lung findings compatible with ILD, enhancing early detection and referral pathways.
Fibresolve (with PCCP)
Imvaria
Clinical Decision Support & Reference
IMVARIA is a health tech company pioneering AI-driven solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease.

See all 3 products →

About Imvaria

Imvaria is a pioneering healthcare AI company that develops AI-driven digital biomarker solutions for serious diseases, primarily focusing on lung conditions. The company’s core innovation lies in generating physiologic signatures from clinical testing and imaging data, which allows for earlier and more accurate diagnoses while potentially reducing the need for invasive procedures.

For physicians, Imvaria offers FDA-authorized AI tools like Fibresolve and ScreenDx. Fibresolve is an AI diagnostic adjunct that analyzes lung CT imaging to provide a diagnostic subtype classification in suspected interstitial lung disease (ILD), specifically assisting in the pre-invasive assessment of idiopathic pulmonary fibrosis (IPF). ScreenDx is an automated background AI algorithm that analyzes CT imaging to detect interstitial lung findings compatible with ILD and flags cases for referral workflows, aiming to reduce diagnostic delays. Imvaria also has an investigational AI tool called Bronchosolve, which is designed to automate risk assessment for suspicious pulmonary nodules detected on screening CTs. The company operates a centralized, cloud-based AI Lab where clinicians, health systems, and clinical trialists can transmit de-identified cases for automated machine learning analysis, receiving diagnostic reports in minutes.

Focus Areas

AI biomarker development clinical imaging diagnostics for ILD and IPF SaMD development and commercialization regulatory strategy for medical AI clinical validation studies cloud-based diagnostic lab services clinical-trial biomarker integration patient stratification automated screening and triage systems for imaging deep learning convolutional neural networks multi-modal data fusion CT image analysis pattern recognition predictive modeling for clinical outcomes de-identification and privacy-preserving data handling

Business Intelligence

TechnologyIMVARIA's AI Lab is a centralized, cloud-based digital lab that utilizes automated, machine-learning algorithm technology. It employs deep learning, convolutional neural networks, and multi-modal data fusion (imaging + labs + clinical data) for analysis. The platform is designed for Software-as-Medical-Device (SaMD) tools, offering a remote service that accepts de-identified clinical cases, runs automated ML analyses, and returns diagnostic reports.

What Physicians Need to Know

Specialization
IMVARIA specializes in AI-driven digital biomarker solutions for serious diseases, primarily focusing on lung fibrosis and interstitial lung disease (ILD). They generate novel physiologic signatures from clinical testing and imaging.
Key Products
Their flagship products include Fibresolve and ScreenDx. Fibresolve is an FDA-authorized AI diagnostic service for idiopathic pulmonary fibrosis (IPF) and ILD, designed to aid in diagnosis prior to invasive testing. ScreenDx is an FDA-cleared AI-powered screening algorithm that automatically analyzes CT scans for findings suggestive of ILD, enhancing referral pathways.
Regulatory Milestones
IMVARIA has achieved significant regulatory milestones, including FDA authorization for Fibresolve (early 2024) and FDA 510(k) clearance for ScreenDx (2025). Fibresolve also holds FDA Breakthrough Device Designation and has adopted CPT billing codes.
Non-Invasive Diagnostics
A core focus is on non-invasive assessment, utilizing existing clinical data and imaging (like CT scans) to provide diagnostic insights, thereby reducing the need for invasive procedures such as biopsies.
Predictive Capabilities
Beyond diagnosis, their tools like Fibresolve have demonstrated the ability to predict outcomes, such as mortality in ILD patients, which can help guide treatment decisions and clinical trial referrals.
Physician Tip

IMVARIA's tools, Fibresolve and ScreenDx, are designed to be adjunctive to current standard-of-care workflows, providing supplementary information to qualified clinicians. They aim to simplify the integration of AI into practice by offering a centralized, cloud-based AI Lab where clinicians can transmit de-identified cases (imaging and lab data) and receive reports with AI analysis results in minutes, without requiring complex software installations or workflow changes. This can lead to earlier and more accurate diagnoses, potentially preventing unnecessary treatments and improving patient outcomes in complex lung diseases.

IMVARIA operates a centralized, cloud-based 'AI Lab' that functions similarly to a specialty CLIA lab, processing data rather than physical samples. This model emphasizes ease of use with 'no integration, no software' required for clinicians; they simply refer cases and receive results. IMVARIA has also formed strategic partnerships, such as with Viz.ai, to expand their pulmonary portfolio and integrate new AI capabilities for assessing ILD. They also offer their AI Lab services to other companies, such as providing InVision's Precision Cardiac Amyloid AI for cardiac amyloidosis detection.

Products by Imvaria

3 products in the directory

Fibresolve
IMVARIA
Clinical Decision Support & Reference
Fibresolve is the first FDA-authorized AI diagnostic service in idiopathic pulmonary fibrosis (IPF) and interstitial lung disease (ILD), using non-invasive analysis to help drive diagnosis.
ScreenDx
IMVARIA
Clinical Decision Support & Reference
ScreenDx is a first-of-its-kind, FDA-cleared AI technology from Imvaria that automatically assesses CT scans for interstitial lung findings compatible with ILD, enhancing early detection and referral pathways.
Fibresolve (with PCCP)
Imvaria
Clinical Decision Support & Reference
IMVARIA is a health tech company pioneering AI-driven solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease.

What the Web Says

Imvaria is a healthcare technology company specializing in AI-driven digital biomarker solutions, with a primary product called ScreenDx. ScreenDx is an FDA-cleared AI-powered algorithm designed to automatically assess CT scans for interstitial lung findings compatible with Interstitial Lung Disease (ILD). The company aims to enhance referral pathways and reduce diagnostic delays for ILD patients by integrating AI into clinical testing and imaging. While there is significant information available about their product's capabilities and FDA clearance, comprehensive independent product and employer reviews on platforms like G2, Glassdoor, Capterra, and Reddit are limited or not directly available for "Imvaria" or "ScreenDx" at this time.

Overall: Positive

Strengths

  • ScreenDx is a first-of-its-kind, FDA-cleared AI technology for assessing CT scans for interstitial lung findings compatible with ILD.
  • The ScreenDx algorithm has demonstrated high performance in identifying incidental cases of pulmonary fibrosis across various CT manufacturers and slice thicknesses, suggesting generalizability.
  • ScreenDx operates as a quiet, background-only technology, automatically sifting through thousands of CT scans without requiring expert user operation.
  • The technology is designed to be supplementary to current standard-of-care workflows, providing adjunctive information to improve referral pathways and reduce diagnostic delays for ILD.
  • Imvaria is pioneering work with clinical AI to redefine how to approach high-impact diseases more effectively.

Limitations

  • Limited independent product reviews for ScreenDx were found on major review platforms like G2, Capterra, and Reddit.
  • No specific employer reviews for "Imvaria" were found on Glassdoor or similar platforms.
  • General concerns about AI in medical diagnostics on Reddit suggest that AI is still in development and may have a high margin of error in detecting normal anatomical differences versus concerning lesions.
  • Some general reviews of AI medical diagnostic platforms mention challenges with complexity, data security, and lack of APIs for interoperability.

Based on reviews from: Business Wire, PubMed, IMVARIA (imvaria.com), MedTech Innovator, G2, Reddit

Last updated: 2026-10-17

Videos

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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 announced its second FDA authorization, securing 510(k) clearance for ScreenDx, an AI-powered tool to assist clinicians in assessing for interstitial lung disease (ILD).
2025-01
Fierce Biotech
FDA grants first clearance to AI program for diagnosing idiopathic pulmonary fibrosis
IMVARIA received De Novo clearance from the FDA for its Fibresolve program, an AI digital diagnostic that analyzes chest CT scans for signs of idiopathic pulmonary fibrosis (IPF), marking the first FDA authorization of a diagnostic tool in lung fibrosis.
2024-01
Business Wire
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 ATS 2025.
2025-05
Business Wire
IMVARIA Announces Strategic Investments from Leading Healthcare Companies
IMVARIA announced strategic investments from new and existing investors, including InHealth Ventures and Labcorp Venture Fund, to accelerate growth and innovation in AI-driven digital healthcare.
2026-01
HealthITAnalytics
IMVARIA's FDA-Cleared ScreenDx Brings AI-Powered Screening to Interstitial Lung Disease
IMVARIA's ScreenDx, an FDA 510(k) cleared algorithm, focuses on early screening and referral pathways for Interstitial Lung Disease (ILD) by analyzing CT scans for suggestive patterns.
2025-01
BioSpace
IMVARIA's AI-Powered, Non-Invasive Bronchosolve Solution Meets Primary Endpoints for Lung Cancer Diagnosis in Pivotal VIRTUAL-BRONCH Study
IMVARIA announced that its new platform, Bronchosolve (investigational), an AI-powered diagnostic solution for assessing suspicious pulmonary nodules, met primary endpoints in the VIRTUAL-BRONCH Study for non-invasive lung cancer diagnosis.
2025-10
IMVARIA
Viz AI Partnership - IMVARIA
IMVARIA partnered with Viz.ai to leverage IMVARIA's FDA-cleared ScreenDx™ technology to enhance Viz.ai's intelligent solutions for identifying patients who may benefit from specialized evaluation and therapy for serious respiratory diseases.
2025-11
IMVARIA
IMVARIA & Medical Horizons
IMVARIA announced a partnership with Medical Horizons to expand the reach of its AI innovations, including Fibresolve and ScreenDx, to pulmonologists in the MENA region.
2025-06

Frequently Asked Questions

Imvaria specializes in AI-powered diagnostic support and personalized treatment recommendations. Our flagship product, 'Imvaria Dx,' assists in early disease detection by analyzing complex patient data, while 'Imvaria Rx' optimizes treatment plans based on individual patient profiles and real-world evidence.
Imvaria's AI algorithms undergo rigorous clinical validation through extensive retrospective and prospective studies. We collaborate with leading medical institutions and publish our findings in peer-reviewed journals to demonstrate accuracy and reliability, ensuring our solutions meet high clinical standards.
Imvaria is fully compliant with HIPAA and GDPR regulations, implementing robust data encryption and access controls to protect patient privacy. Our products are developed with a clear regulatory pathway in mind, and we actively pursue necessary FDA clearances and other relevant health authority approvals for our medical devices.
Imvaria offers flexible pricing models, including subscription-based licenses and per-use fees, tailored to the size and needs of your organization. Costs typically include initial implementation, ongoing software access, and dedicated technical support, with transparent breakdowns provided during the consultation phase.
Imvaria provides comprehensive support, including dedicated account management, 24/7 technical assistance, and regular software updates. We offer extensive training programs for clinical staff and IT teams to ensure seamless integration and optimal utilization of our AI platforms.
Yes, Imvaria's solutions are designed for seamless integration with major EHR systems and other healthcare IT infrastructure through standard APIs. Our implementation process involves a dedicated team that works closely with your IT department to ensure a smooth, efficient, and secure integration tailored to your specific environment.
Imvaria is backed by strong venture capital funding and has a clear long-term vision for innovation in healthcare AI. We are committed to continuous product development and maintain a robust financial outlook, ensuring the sustained availability and evolution of our solutions for our partners.

Investors

Who's funded Imvaria.

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