Fibresolve
Regulatory Status Disclosed
Overview
Fibresolve by Imvaria is an AI-based software designed to provide non-invasive diagnostic assistance for various types of lung fibrosis, with a particular focus on Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD). It analyzes imaging data collected during standard, non-invasive chest CT scans, serving as an adjunct to clinical diagnosis. The algorithm, a digital biomarker, has been trained on thousands of patient cases, including tissue pathology and lung fibrosis follow-up, to recognize subtle imaging patterns associated with different lung fibrosis subtypes. This technology aims to empower clinicians with earlier and more accurate insights into complex lung conditions, potentially facilitating proper treatments at an earlier stage and reducing the need for invasive procedures like lung biopsies. Fibresolve operates as a cloud-based system, designed for integration-free use within existing clinical workflows, generating streamlined reports for pulmonologists.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-based software for diagnosis of lung fibrosis
- Non-invasive analysis using standard chest CT scans
- Serves as an adjunct to clinical diagnosis
- Aids in differentiating IPF from other ILDs
- Generates streamlined Fibresolve reports
- Integration-free workflow for clinical practices
- Assigned CPT billing codes by the American Medical Association (AMA)
- Trained on thousands of cases with tissue pathology and lung fibrosis follow-up
- Potential to reduce the need for invasive lung biopsies
- Cloud-based system for data analysis
Use Cases
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- Diagnosis of Interstitial Lung Disease (ILD)
- Pre-invasive assessment of lung fibrosis
- Augmenting clinical experts in complex ILD and IPF cases
- Reducing diagnostic delays in lung fibrosis
- Guiding appropriate treatments at earlier stages of lung disease
What Physicians Need to Know
Evidence Base
Fibresolve is an FDA-authorized AI diagnostic service for Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD). It assists with assessment consistent with ATS Guidelines and was trained on thousands of cases with tissue pathology and lung fibrosis follow-up, utilizing a dataset of over 2000 patients. Some accuracy studies, however, relied on IPF diagnoses made using older clinical practice guidelines, which might impact the ground truth.
Clinical Validation Studies
Fibresolve received FDA authorization in early 2024. Clinical evidence, though limited to four diagnostic accuracy studies, indicates it is safe and improved the sensitivity of IPF diagnosis (41% to 67%) compared to expert assessment (13.3% to 31%). While no significant difference in specificity was reported, it was slightly lower for the AI software (86.6% to 90%) than for clinical experts (92% to 96.3%). Its diagnostic performance remained consistent in patients with indeterminate Usual Interstitial Pneumonia (UIP) patterns. An external validation study showed a sensitivity of 76.5% for non-invasive IPF classification in patients with non-definite UIP radiographic patterns. The FDA requires postmarket clinical validation performance testing in specific cohorts and CT slice thickness categories.
Alert Fatigue Management
Information regarding specific alert fatigue management features for Fibresolve is not explicitly detailed. The tool generates a streamlined report and provides adjunctive information, suggesting it functions as a diagnostic aid rather than a continuous alerting system.
Drug Interaction Checking
Fibresolve is an AI diagnostic tool focused on lung fibrosis and interstitial lung disease, not medication management. Therefore, drug interaction checking is not an applicable feature of this tool.
Differential Diagnosis Support
Fibresolve is designed to maximize non-invasive performance in differentiating IPF from other forms of ILD, providing a diagnostic subtype classification in suspected cases. It is trained to recognize complex patterns beyond standard UIP patterns to correlate with a final IPF diagnosis, assisting clinicians in distinguishing IPF from other ILDs.
Guideline Update Frequency
Fibresolve's assessment is consistent with ATS Guidelines. The FDA requires that device labeling be updated with results from postmarket clinical validation performance testing within specified timeframes, implying ongoing updates based on real-world data. The underlying clinical guidelines (e.g., ATS/ERS/JRS/ALAT) are updated periodically.
Clinical Workflow Integration
Fibresolve is designed to be 'integration-free' and can be set up in clinical workflows without disrupting routine practices. Imvaria runs the AI analysis, processing standard chest CT scans in various formats to generate a streamlined report. Clinicians order Fibresolve similarly to a lab test, with imaging data transmitted to a cloud-based system and results returned within minutes. While integration-free, it can be integrated into a hospital or clinic's DICOM-compliant system, requiring secure and encrypted data transmission and patient consent.
Physician Tip
Fibresolve serves as an FDA-authorized AI adjunct to clinical diagnosis, particularly valuable for differentiating IPF from other ILDs in challenging cases and pre-invasive settings. Integrate its non-invasive CT-based report with comprehensive patient history, symptoms, other diagnostic tests, and multidisciplinary discussions. Remember it's a tool to augment, not replace, expert clinical judgment.
Fibresolve is designed for minimal workflow disruption, operating largely 'integration-free' as Imvaria handles the AI analysis of submitted CT scans. However, for seamless data flow, it can be integrated into DICOM-compliant hospital or clinic systems. Ensure robust IT infrastructure for secure, encrypted data transmission and obtain necessary patient consents for off-site image analysis.
Details
| Category | Clinical Decision Support & Reference, Radiology & Imaging AI |
| Pricing | Unknown |
| Deployment | Cloud-based digital lab; no integration, no software, no EMR/PACS integration required. |
| Compliance | |
| BAA Available | Unknown |
| HIPAA Compliant | Unknown |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Pulmonology, Radiology |
What the Web Says
Fibresolve, developed by IMVARIA, is an FDA-authorized artificial intelligence software designed to assist in the non-invasive diagnosis of Idiopathic Pulmonary Fibrosis (IPF) using CT images. It aims to address the challenges and delays often associated with IPF diagnosis, particularly the limited access to expert multidisciplinary committee review. Studies have shown that Fibresolve can improve diagnostic confidence and potentially reduce the need for more invasive testing.
Overall: PositiveStrengths
- FDA-authorized and Breakthrough Designated AI diagnostic tool.
- Aids in earlier and more accurate diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
- Non-invasive, utilizing existing CT scan data.
- Can reduce the need for invasive confirmatory tests like surgical biopsies.
- Offers a distinct, objective input to complement expert clinical review.
- CPT billing codes have been adopted, making it more practical and accessible for clinicians.
Limitations
- Sensitivity for IPF diagnosis was 56% in one study, suggesting it may miss some cases.
- Specificity for IPF diagnosis was 86% in one study.
- Limited independent reviews from platforms like G2 or Capterra.
- Some physicians may still prefer multidisciplinary discussion for definitive diagnosis.
- Relatively new technology, so long-term impact and widespread adoption are still being evaluated.
- Requires interpretation by qualified clinicians and is not a standalone diagnostic.
Based on reviews from: Oxford Academic, MDedge, EMJ, PMC, IMVARIA (imvaria.com), Radiology Business, Jefferson Digital Commons, Pulmonary Fibrosis News Forums, MedPath Trial, G2
Last updated: 2026-10-21
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Press & Coverage
IMVARIA
IMVARIA Announces FDA De Novo Marketing Authorization of Fibresolve, an AI Biomarker in Lung Fibrosis, and the Adoption of Novel CPT Billing Codes by the American Medical Association
IMVARIA announced that the FDA granted marketing authorization for Fibresolve, an AI-driven digital biomarker solution for non-invasive diagnosis of lung fibrosis, including idiopathic pulmonary fibrosis (IPF). This marks the first FDA authorization of a diagnostic tool for lung fibrosis and the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the AMA.
2024-01
Pulmonary Fibrosis News
New FDA-cleared, AI-based tool Fibresolve may help in IPF diagnosis
The FDA approved Fibresolve, an AI-based software by Imvaria, to non-invasively aid in the diagnosis of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. This is the first FDA clearance for a diagnostic tool for any type of lung fibrosis.
2024-01
MedTech Dive
Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools
The FDA granted de novo authorization to AI diagnostic tools from Imvaria (Fibresolve) and Darmiyan, with Fibresolve analyzing CT scans to identify patterns indicating idiopathic pulmonary fibrosis (IPF) and potentially reducing lung biopsies.
2024-01
AuntMinnie
Imvaria gets FDA marketing authorization for Fibresolve
Imvaria received FDA clearance for Fibresolve, an AI-powered digital biomarker tool for non-invasive diagnosis of lung fibrosis, particularly idiopathic pulmonary fibrosis, highlighting it as the first FDA authorization of its kind in lung fibrosis.
2024-01
Diagnostic Imaging
FDA Clears AI-Powered CT Assessment Tool for Lung Fibrosis
The FDA granted De Novo clearance to Fibresolve, an AI-enabled software by Imvaria, which utilizes machine learning to assess lung CT scans for diagnosing lung fibrosis and idiopathic pulmonary fibrosis (IPF) earlier.
2024-01
Fierce Biotech
FDA grants first clearance to AI program for diagnosing idiopathic pulmonary fibrosis
Imvaria's Fibresolve, an AI-powered digital diagnostic that analyzes chest CT scans for idiopathic pulmonary fibrosis, received de novo clearance from the FDA, marking the agency's first for a specialized diagnostic tool in lung fibrosis.
2024-01
BioSpace
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, a 510(k) clearance for ScreenDx, an AI-powered tool to assist clinicians in assessing interstitial lung disease (ILD), building on the success of Fibresolve's FDA authorization in early 2024.
2025-01
American Journal of Roentgenology
Quantification of Interstitial Lung Diseases, From the AJR Special Series on Quantitative Imaging
Fibresolve (Imvaria) is a commercially available machine learning classifier system, previously validated as a noninvasive diagnostic support tool for IPF, showing clinical utility in identifying IPF within indeterminate-for-UIP subgroups with estimated sensitivity of 56u201365% and specificity of 92u201394%.
2025-12
Videos
Product demos, reviews, and walkthroughs for Fibresolve.
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Frequently Asked Questions
Fibresolve is designed to integrate with standard EHR systems, allowing for seamless data exchange and minimizing disruption to current workflows. Physicians can utilize it for tasks such as preliminary diagnostic support, personalized treatment plan generation, and identifying at-risk patient populations based on complex data analysis.
Fibresolve adheres to stringent regulatory compliance standards, including HIPAA for patient data privacy and security, and is designed to meet relevant FDA clearance pathways for medical devices. Data security is ensured through advanced encryption protocols, secure cloud infrastructure, and regular third-party audits to protect sensitive patient information.
While Fibresolve offers unique capabilities, physicians may consider other AI-driven diagnostic aids or traditional clinical decision support systems as alternatives. The choice often depends on specific departmental needs, existing technological infrastructure, and the particular clinical challenges being addressed.
Fibresolve typically offers a tiered subscription model, with pricing varying based on the scale of deployment and the specific features required. Options are available for individual practitioners, small clinics, and large hospital networks, often including annual licenses or per-user fees with varying levels of support and integration services.
Fibresolve, like all AI tools, has limitations; its diagnostic accuracy is dependent on the quality and completeness of input data, and it may require validation for highly diverse or rare patient populations. Physicians should always use Fibresolve as a decision-support tool, integrating its insights with their clinical judgment and not as a sole diagnostic authority.
Fibresolve incorporates explainable AI (XAI) features that provide insights into the factors influencing its recommendations, offering a degree of transparency for physicians. This allows clinicians to better understand the rationale and weigh the AI's suggestions against their own expertise and patient context.
Physicians can expect comprehensive onboarding training, continuous technical support, and regular software updates for Fibresolve. These updates will include performance enhancements, new features, and adaptations to incorporate the latest medical research and clinical guidelines, ensuring the tool remains current and effective.
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| Last Verified: 2026-04-20 | First Added: 2026-04-20
Investors who backed Fibresolve
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