Clinical Utility of an FDA-Authorized Artificial Intelligence Imaging Platform in Interstitial Lung Disease Diagnosis

Background/Objectives: The diagnosis of interstitial lung disease (ILD) is challenging and frequently delayed. Clinically accessible and minimally invasive diagnostic tools are needed to expedite the diagnosis of ILD while minimizing risk to patients. Fibresolve is an imaging artificial intelligence (AI) tool recently approved by the Food and Drug Administration (FDA) for use in ILD diagnosis and made available to clinicians. The objective of this study was to describe its utility in clinical practice. Methods: We conducted a prospective, observational study of patients across the United States (US) in whom Fibresolve was utilized during routine clinical practice between July 2024 and June 2026. Information on patient demographics, Fibresolve test results (positive = suggestive of idiopathic pulmonary fibrosis (IPF); negative = unsupportive of IPF), and disease management pre- and post-Fibresolve utilization were collected, including the use of ILD-specific pharmacotherapy and planned and/or completed invasive diagnostic procedures. Results: There were 209 patients that underwent evaluation with Fibresolve across 47 medical centers. Of those, 16 were academic centers (n = 57 patients), and 31 were community-based (n = 152 patients). Fibresolve was positive in 89/209 (42.6%) patients. The percentage of patients receiving ILD-specific pharmacotherapy increased significantly following Fibresolve utilization (12.5% to 44.4%, p < 0.001). Pre-Fibresolve, 59/154 (38.3%) patients had an invasive diagnostic procedure planned; post-Fibresolve, only 12/77 (15.6%) patients had an invasive procedure performed (p < 0.001). Conclusions: In this real-world study evaluating the use of an FDA-authorized imaging tool for ILD diagnosis in diverse clinical practices across the US, we found that following utilization of Fibresolve, there was a statistically significant increase in the percentage of patients receiving guideline-directed therapy for ILD, and previously-planned invasive diagnostic procedures were avoided in many cases. These findings support the use of Fibresolve as an adjunct for ILD diagnosis in clinical practice.