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 serves as a valuable FDA-authorized adjunct tool for non-invasive assessment of ILD and IPF, particularly in challenging cases. It can significantly improve diagnostic sensitivity and aid in differentiating IPF from other ILDs. Remember to use the Fibresolve report in conjunction with the patient's full clinical history, symptoms, other diagnostic tests, and your professional judgment. It is designed to augment, not replace, expert clinical decision-making, potentially reducing the need for invasive procedures.
Fibresolve operates as a centralized service, meaning it is 'integration-free' from the perspective of direct EHR system integration at the point of care. Physicians send CT scan data to IMVARIA for analysis, and a report is returned. This cloud-based approach simplifies deployment but requires secure data transmission protocols for patient imaging data to IMVARIA's central processing center.
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 |
1 AI-estimated Fibresolve (with PCCP) received FDA 510(k) clearance (K252041) on November 7, 2025, for Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. It also received FDA Breakthrough Device Designation and De Novo marketing authorization in early 2024. |
| Integrations | |
| EHR | Not specified |
| Specialties | Pulmonology, Radiology |
What the Web Says
Fibresolve (with PCCP) is an AI-powered software designed to assist in the non-invasive diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and other interstitial lung diseases (ILDs) by analyzing CT imaging data. It has received FDA De Novo marketing authorization and Breakthrough Device Designation, marking it as the first FDA-authorized diagnostic tool for lung fibrosis. The system aims to improve diagnostic accuracy and reduce the need for invasive procedures like surgical biopsies, particularly in challenging cases where traditional methods may be inconclusive. Additionally, Fibresolve has been shown to be associated with mortality in ILD patients, suggesting its potential role in prognostication.
Overall: PositiveStrengths
- Increases sensitivity and diagnostic yield for IPF, especially in challenging cases with atypical UIP patterns.
- Non-invasive, utilizing existing CT scan data, which can reduce the need for invasive surgical biopsies.
- FDA-authorized and granted Breakthrough Device Designation, indicating its potential for significant clinical impact.
- Provides an adjunct to clinical experts, augmenting their assessment in the pre-invasive setting.
- Has established CPT billing codes from the American Medical Association, facilitating its integration into medical practice and reimbursement.
- May predict mortality in ILD patients, offering potential for improved prognostication.
Limitations
- Evidence is primarily limited to diagnostic accuracy studies, with some experts suggesting it's premature to consider it a preferred software among ILD experts.
- The AI output may not always correlate with radiological opinion.
- The classifier's specificity was not statistically or significantly different compared to the Expert Clinical Panel in the full 300 cases, and trended lower.
- Cannot be used to rule out IPF.
- Results should not be solely relied upon for referral, patient follow-up, or management, and must be used in conjunction with other clinical findings and professional judgment.
- Requires series slice thickness of < 3mm for input CT scans.
Based on reviews from: PMC, Respiratory Therapy, ResearchGate, Pulmonary Fibrosis News, Diagnostic Imaging, IMVARIA Inc., FDA, Reddit, Capterra, Trustpilot
Last updated: 2026-07-18
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