Fibresolve (with PCCP)
Overview
Fibresolve (with PCCP) by Imvaria is a software-only medical device designed to assist in the qualitative assessment of fibrotic lung disease. It utilizes machine learning and deep-learning algorithms to analyze DICOM-compliant high-resolution computed tomography (HRCT) lung scans, providing a diagnostic subtype classification for suspected cases of interstitial lung disease (ILD). Specifically, the tool serves as a non-invasive diagnostic adjunct to support the pre-invasive assessment of idiopathic pulmonary fibrosis (IPF).
The tool is intended for use by pulmonologists, radiologists, and other clinicians qualified in the care of lung diseases. It is typically utilized within pulmonology clinics, radiology departments, and multidisciplinary discussion (MDD) environments.
In a clinical workflow, Fibresolve integrates by receiving standard chest CT imaging data. It processes these scans to generate an automated diagnostic report that supplements standard-of-care evaluations. Clinicians use the resulting machine-learning pattern recognition outputs alongside the patient’s clinical history, symptoms, and other diagnostic tests to guide referral pathways and inform MDD decision-making.
- Non-Invasive Subtype Classification: Analyzes standard lung CT scans to help identify and classify IPF patterns prior to invasive surgical biopsies.
- Predetermined Change Control Plan (PCCP): Incorporates an authorized PCCP to manage software updates and algorithm modifications systematically.
- Seamless Workflow Integration: Processes standard DICOM-compliant imaging data to generate clinical reports without requiring specialized hardware.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-driven diagnostic tool for lung fibrosis
- Non-invasive assessment of ILD and IPF
- Analyzes standard chest CT scans
- Provides diagnostic subtype classification
- Offers adjunctive information for clinicians
- Designed for integration-free workflow
- FDA-authorized and Breakthrough-Designated
- Associated with CPT billing codes by the AMA
- Reduces the need for invasive biopsy testing
- Aids in earlier and accurate insights into complex conditions
Use Cases
- Assessing patients with suspected interstitial lung disease (ILD)
- Diagnosing idiopathic pulmonary fibrosis (IPF)
- Guiding safe, non-invasive diagnoses
- Facilitating proper treatments at an earlier stage of disease
- Augmenting clinical experts in the pre-invasive setting
- Improving disease detection and reducing diagnostic delays
What Physicians Need to Know
Fibresolve is an FDA Breakthrough Designated and Authorized AI diagnostic tool intended as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing. It analyzes non-invasively collected data, specifically DICOM-compliant lung CT scans, and can incorporate age, sex, and FVC. The results should be used by clinicians qualified in lung disease care, in conjunction with the patient's clinical history, symptoms, other diagnostic tests, and professional judgment. It can be particularly useful in new ILD workups, cases with indeterminate CT patterns, or when diagnostic uncertainty exists. Fibresolve has demonstrated improved sensitivity for IPF diagnosis compared to expert assessment based on clinical and radiological data. The tool has also been shown to predict mortality in ILD patients. The AMA has established CPT code 0880T for the professional interpretation associated with AI-based CT analysis in interstitial lung disease.
Fibresolve is a software-only device that receives and analyzes lung CT imaging data. Hospitals or clinics can access the API directly via secure software integration to submit images electronically, or images can be transmitted manually to the device manufacturer for submission through the API. The system does not require EMR/PACS integration.
Details
| Category | Clinical Decision Support & Reference, Radiology & Imaging AI |
| Pricing | Contact vendor for pricing. |
| Deployment | Cloud-based centralized service. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Pulmonology, Radiology |
What the Web Says
Fibresolve, developed by IMVARIA Inc., is an AI-powered diagnostic tool that analyzes chest CT scans and other clinical data to aid in the non-invasive diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and other Interstitial Lung Diseases (ILDs). It received FDA authorization in January 2024 and has been shown to improve diagnostic accuracy, particularly in challenging cases, and reduce the need for invasive procedures. The company has also developed Fibresolve version 2 (v2) under the FDA's Predetermined Change Control Plan (PCCP) framework, which incorporates additional patient data for improved performance.
Overall: PositiveStrengths
- Aids in the non-invasive diagnosis of IPF and ILD, reducing the need for invasive procedures like lung biopsies.
- Improves diagnostic sensitivity and specificity, especially in cases with indeterminate CT patterns or atypical presentations.
- Reduces the burden on clinicians by centralizing software analysis and generating rapid reports.
- Widely accessible, usable at any center with standard CT scans, and does not require hyper-specialized providers.
- FDA-authorized and has received CPT billing codes from the American Medical Association, making it a viable and cost-effective option.
- Version 2 (v2) shows modest, directionally favorable improvements in performance by incorporating age, sex, and forced vital capacity.
Limitations
- Sensitivity can be moderate in some validation studies (e.g., 41% in one study).
- Some community members express concern about the cost of the AI tool and hope for its integration into more accessible platforms.
- The tool is an adjunct to clinical assessment, and clinicians still need to decide if they have sufficient information to avoid a biopsy.
- The long-term impact on patient outcomes and clinical integration challenges are still being evaluated.
- One community member expressed skepticism about how soon such AI tests would be used as a diagnostic tool.
- The studies primarily focus on diagnostic performance and reduction of invasive procedures, with less emphasis on direct patient experience or feedback from a wider range of healthcare professionals beyond physicians.
Based on reviews from: researchgate.net, pulmonaryfibrosisnews.com, mdedge.com, nih.gov, fda.gov, rhizomeai.com, radiologybusiness.com, imvaria.com, emjreviews.com, fiercebiotech.com, mdpi.com
Last updated: 2026-10-30
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