{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T08:47:00Z","timestamp":1785746820026,"version":"3.56.0"},"reference-count":55,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T00:00:00Z","timestamp":1785715200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>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 &lt; 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 &lt; 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.<\/jats:p>","DOI":"10.3390\/diagnostics16152445","type":"journal-article","created":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T08:04:59Z","timestamp":1785744299000},"page":"2445","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical Utility of an FDA-Authorized Artificial Intelligence Imaging Platform in Interstitial Lung Disease Diagnosis"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7099-4560","authenticated-orcid":false,"given":"Arjun Prakash","family":"Tambe","sequence":"first","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Department of Medicine, Northwestern University, Chicago, IL 60611, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3750-1311","authenticated-orcid":false,"given":"Ryan D.","family":"Boente","sequence":"additional","affiliation":[{"name":"Division of Pulmonary, Critical Care, Allergy and Occupational Medicine, Department of Medicine, Indiana University, Indianapolis, IN 46202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gautam","family":"George","sequence":"additional","affiliation":[{"name":"Jane and Leonard Korman Respiratory Institute, Division of Pulmonary, Allergy and Critical Care Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fayez","family":"Kheir","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omid","family":"Tahamtani Omran","sequence":"additional","affiliation":[{"name":"Independent Researcher, Los Angeles, CA 90095, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0988-0222","authenticated-orcid":false,"given":"Kavitha C.","family":"Selvan","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Department of Medicine, Northwestern University, Chicago, IL 60611, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,3]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e18","DOI":"10.1164\/rccm.202202-0399ST","article-title":"Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS\/ERS\/JRS\/ALAT Clinical Practice Guideline","volume":"205","author":"Raghu","year":"2022","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1051","DOI":"10.1002\/acr.25348","article-title":"2023 American College of Rheumatology (ACR)\/American College of Chest Physicians (CHEST) Guideline for the Treatment of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Diseases","volume":"76","author":"Johnson","year":"2024","journal-title":"Arthritis Care Res."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1016\/j.ard.2025.08.021","article-title":"ERS\/EULAR clinical practice guidelines for connective tissue disease-associated interstitial lung disease developed by the task force for connective tissue disease-associated interstitial lung disease of the European Respiratory Society (ERS) and the European Alliance of Associations for Rheumatology (EULAR) Endorsed by the European Reference Network on rare respiratory diseases (ERN-LUNG)","volume":"85","author":"Antoniou","year":"2026","journal-title":"Ann. Rheum. Dis."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"210169","DOI":"10.1183\/16000617.0169-2021","article-title":"Diagnosis, course and management of hypersensitivity pneumonitis","volume":"31","author":"Hamblin","year":"2022","journal-title":"Eur. Respir. Rev."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"442","DOI":"10.1111\/all.15017","article-title":"Hypersensitivity pneumonitis: Current concepts in pathogenesis, diagnosis, and treatment","volume":"77","author":"Barnes","year":"2022","journal-title":"Allergy"},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Cosgrove, G.P., Bianchi, P., Danese, S., and Lederer, D.J. (2018). Barriers to timely diagnosis of interstitial lung disease in the real world: The INTENSITY survey. BMC Pulm. Med., 18.","DOI":"10.1186\/s12890-017-0560-x"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1350","DOI":"10.1016\/j.rmed.2006.10.002","article-title":"Patient experiences with pulmonary fibrosis","volume":"101","author":"Collard","year":"2007","journal-title":"Respir. Med."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"e002333","DOI":"10.1136\/bmjresp-2024-002333","article-title":"The diagnostic pathway for patients with interstitial lung disease: A mixed-methods study of patients and physicians","volume":"11","author":"Pooler","year":"2024","journal-title":"BMJ Open Respir. Res."},{"key":"ref_9","unstructured":"Dilling, D.F., Glennie, J., Hernandez, T., Kershaw, C.D., Kulkarni, T., Lago, W., Limper, A.H., Nambiar, A.M., and Scholand, M.B. (2022). State of Practice: Factors Driving Diagnostic Delays in Idiopathic Pulmonary Fibrosis, CHEST Clinical Perspectives."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"788","DOI":"10.1164\/rccm.2009-040GL","article-title":"An Official ATS\/ERS\/JRS\/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management","volume":"183","author":"Raghu","year":"2011","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Fern\u00e1ndez Fabrellas, E., Peris S\u00e1nchez, R., Sabater Abad, C., and Juan Samper, G. (2018). Prognosis and Follow-Up of Idiopathic Pulmonary Fibrosis. Med. Sci., 6.","DOI":"10.3390\/medsci6020051"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1016\/j.rmed.2015.02.002","article-title":"Natural history of idiopathic pulmonary fibrosis","volume":"109","author":"Kim","year":"2015","journal-title":"Respir. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1016\/j.pccm.2025.02.001","article-title":"Advances in idiopathic pulmonary fibrosis diagnosis and treatment","volume":"3","author":"Liu","year":"2025","journal-title":"Chin. Med. J. Pulm. Crit. Care Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1111\/crj.13466","article-title":"Idiopathic pulmonary fibrosis: Current and future treatment","volume":"16","author":"Glass","year":"2022","journal-title":"Clin. Respir. J."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2071","DOI":"10.1056\/NEJMoa1402584","article-title":"Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis","volume":"370","author":"Richeldi","year":"2014","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"190158","DOI":"10.1183\/16000617.0158-2019","article-title":"Prognosis of idiopathic pulmonary fibrosis without anti-fibrotic therapy: A systematic review","volume":"29","author":"Khor","year":"2020","journal-title":"Eur. Respir. Rev."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1111\/resp.14656","article-title":"Treatment of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis: A position statement from the Thoracic Society of Australia and New Zealand 2023 revision","volume":"29","author":"Mackintosh","year":"2024","journal-title":"Respirology"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"124","DOI":"10.1183\/23120541.00124-2019","article-title":"Gaps in care of patients living with pulmonary fibrosis: A joint patient and expert statement on the results of a Europe-wide survey","volume":"5","author":"Moor","year":"2019","journal-title":"ERJ Open Res."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1416","DOI":"10.1016\/j.chest.2018.03.026","article-title":"Diagnostic Ability of a Dynamic Multidisciplinary Discussion in Interstitial Lung Diseases","volume":"153","author":"Meert","year":"2018","journal-title":"Chest"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1164\/rccm.201104-0668OC","article-title":"Delayed Access and Survival in Idiopathic Pulmonary Fibrosis","volume":"184","author":"Lamas","year":"2011","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1054","DOI":"10.1164\/rccm.200606-833OC","article-title":"Idiopathic Interstitial Pneumonia","volume":"175","author":"Flaherty","year":"2007","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Althobiani, M.A., Russell, A.-M., Jacob, J., Ranjan, Y., Folarin, A.A., Hurst, J.R., and Porter, J.C. (2024). Interstitial lung disease: A review of classification, etiology, epidemiology, clinical diagnosis, pharmacological and non-pharmacological treatment. Front. Med., 11.","DOI":"10.3389\/fmed.2024.1296890"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1164\/rccm.200503-483OE","article-title":"Clinical advances in the diagnosis and therapy of the interstitial lung diseases","volume":"172","author":"King","year":"2005","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Hovinga, M., Sprengers, R., Kauczor, H.-U., and Schaefer-Prokop, C. (2016). CT Imaging of Interstitial Lung Diseases. Multidetector-Row CT of the Thorax, Springer International Publishing.","DOI":"10.1007\/978-3-319-30355-0_7"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1055\/s-0033-1363458","article-title":"High-resolution CT of interstitial lung disease: A continuous evolution","volume":"35","author":"Walsh","year":"2014","journal-title":"Semin. Respir. Crit. Care Med."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"908","DOI":"10.1016\/j.chest.2023.11.037","article-title":"Pictorial Review of Fibrotic Interstitial Lung Disease on High-Resolution CT Scan and Updated Classification","volume":"165","author":"Brixey","year":"2024","journal-title":"Chest"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1007\/s003300000648","article-title":"High-resolution CT of diffuse interstitial lung disease: Key findings in common disorders","volume":"11","author":"Prokop","year":"2001","journal-title":"Eur. Radiol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"e44","DOI":"10.1164\/rccm.201807-1255ST","article-title":"Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS\/ERS\/JRS\/ALAT Clinical Practice Guideline","volume":"198","author":"Raghu","year":"2018","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"AB015","DOI":"10.21037\/jtd.2016.s015","article-title":"AB015. Current diagnostic approaches in ILD: ILD vs. non-specialty clinics","volume":"8","author":"Belloli","year":"2016","journal-title":"J. Thorac. Dis."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"2038","DOI":"10.1001\/jama.2026.7908","article-title":"Cryobiopsy vs Forceps for Bronchoscopic Lung Biopsy: The FROSTBITE-2 Randomized Clinical Trial","volume":"335","author":"Thiboutot","year":"2026","journal-title":"JAMA"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1453","DOI":"10.1183\/13993003.00378-2016","article-title":"Surgical lung biopsy for the diagnosis of interstitial lung disease in England: 1997\u20132008","volume":"48","author":"Hutchinson","year":"2016","journal-title":"Eur. Respir. J."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1016\/j.athoracsur.2009.04.002","article-title":"Diagnostic surgical lung biopsies for suspected interstitial lung diseases: A retrospective study","volume":"88","author":"Sigurdsson","year":"2009","journal-title":"Ann. Thorac. Surg."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1801164","DOI":"10.1183\/13993003.01164-2018","article-title":"Procedure volume and mortality after surgical lung biopsy in interstitial lung disease","volume":"53","author":"Fisher","year":"2019","journal-title":"Eur. Respir. J."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"1600","DOI":"10.1378\/chest.127.5.1600","article-title":"Outcomes and safety of surgical lung biopsy for interstitial lung disease","volume":"127","author":"Lettieri","year":"2005","journal-title":"Chest"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"9439","DOI":"10.21037\/jtd-2025-1365","article-title":"Survey of physicians\u2019 approaches to the clinical evaluation of interstitial lung disease in Singapore (SoPhoCLES)","volume":"17","author":"Teo","year":"2025","journal-title":"J. Thorac. Dis."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1136\/thoraxjnl-2015-207252","article-title":"Interobserver agreement for the ATS\/ERS\/JRS\/ALAT criteria for a UIP pattern on CT","volume":"71","author":"Walsh","year":"2016","journal-title":"Thorax"},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"107428","DOI":"10.1016\/j.rmed.2023.107428","article-title":"Development and validation of a CT-based deep learning algorithm to augment non-invasive diagnosis of idiopathic pulmonary fibrosis","volume":"219","author":"Maddali","year":"2023","journal-title":"Respir. Med."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1164\/rccm.202112-2684OC","article-title":"Deep Learning-based Outcome Prediction in Progressive Fibrotic Lung Disease Using High-Resolution Computed Tomography","volume":"206","author":"Walsh","year":"2022","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1002\/resp.70246","article-title":"Deep-Learning Algorithm Diagnostic Support for Usual Interstitial Pneumonia Pattern Recognition in Fibrotic Interstitial Lung Disease","volume":"31","author":"Fermoyle","year":"2026","journal-title":"Respirology"},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"204","DOI":"10.1183\/09031936.00071812","article-title":"Automated quantification of radiological patterns predicts survival in idiopathic pulmonary fibrosis","volume":"43","author":"Maldonado","year":"2014","journal-title":"Eur. Respir. J."},{"key":"ref_41","unstructured":"(2026, May 23). IQ-UIP. 4DMedical, Available online: https:\/\/4dmedical.com\/products\/software\/iq-uip\/."},{"key":"ref_42","doi-asserted-by":"crossref","unstructured":"Ahmad, Y., Mooney, J., Allen, I.E., Seaman, J., Kalra, A., Muelly, M., and Reicher, J. (2024). A Machine Learning System to Indicate Diagnosis of Idiopathic Pulmonary Fibrosis Non-Invasively in Challenging Cases. Diagnostics, 14.","DOI":"10.3390\/diagnostics14080830"},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1016\/j.amjms.2023.12.009","article-title":"External validation of Fibresolve, a machine-learning algorithm, to non-invasively diagnose idiopathic pulmonary fibrosis","volume":"367","author":"Bradley","year":"2024","journal-title":"Am. J. Med. Sci."},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"297","DOI":"10.1007\/s10278-023-00914-w","article-title":"Analysis of Validation Performance of a Machine Learning Classifier in Interstitial Lung Disease Cases Without Definite or Probable Usual Interstitial Pneumonia Pattern on CT Using Clinical and Pathology-Supported Diagnostic Labels","volume":"37","author":"Chang","year":"2024","journal-title":"J. Imaging Inform. Med."},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"670","DOI":"10.1016\/j.resinv.2024.05.010","article-title":"Computed tomography machine learning classifier correlates with mortality in interstitial lung disease","volume":"62","author":"Singla","year":"2024","journal-title":"Respir. Investig."},{"key":"ref_46","doi-asserted-by":"crossref","unstructured":"Cadham, C.J., Reicher, J., Muelly, M., and Hutton, D.W. (2025). Cost-effectiveness of novel diagnostic tools for idiopathic pulmonary fibrosis in the United States. BMC Health Serv. Res., 25.","DOI":"10.1186\/s12913-025-12506-1"},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"S226","DOI":"10.1016\/j.acra.2021.05.014","article-title":"Artificial Intelligence for Interstitial Lung Disease Analysis on Chest Computed Tomography: A Systematic Review","volume":"29","author":"Soffer","year":"2022","journal-title":"Acad. Radiol."},{"key":"ref_48","unstructured":"Ochs, R. (2026, June 07). Fibresolve FDA Approval, Available online: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf22\/DEN220040.pdf."},{"key":"ref_49","unstructured":"Brainomix (2026, June 07). Brainomix Achieves Breakthrough with FDA Clearance of e-Lung AI Software. Available online: https:\/\/www.prnewswire.com\/news-releases\/brainomix-achieves-breakthrough-with-fda-clearance-of-e-lung-ai-software-302144832.html."},{"key":"ref_50","unstructured":"Jiang, L. (2026, June 07). e-Lung FDA Approval, Available online: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf24\/K242411.pdf."},{"key":"ref_51","unstructured":"Martin, M. (2026, June 07). 4DMedical Receives U.S. FDA Clearance for IQ-UIPTM. 4DMedical. Available online: https:\/\/4dmedical.com\/4dmedical-receives-u-s-fda-clearance-for-iq-uip\/."},{"key":"ref_52","unstructured":"Lamb, J. (2026, June 07). IQ-UIP FDA Approval, Available online: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf24\/K242467.pdf."},{"key":"ref_53","unstructured":"(2026, May 23). Brainomix 360 e-Lung. Brainomix, Available online: https:\/\/www.brainomix.com\/lung\/."},{"key":"ref_54","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1590\/s1806-37562016000000368","article-title":"Usual interstitial pneumonia: Typical, possible, and \u201cinconsistent\u201d patterns","volume":"43","author":"Torres","year":"2017","journal-title":"J. Bras. Pneumol."},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"483","DOI":"10.2147\/CLEP.S54815","article-title":"Epidemiology of idiopathic pulmonary fibrosis","volume":"5","author":"Ley","year":"2013","journal-title":"Clin. Epidemiol."}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/16\/15\/2445\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T08:12:33Z","timestamp":1785744753000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/16\/15\/2445"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,3]]},"references-count":55,"journal-issue":{"issue":"15","published-online":{"date-parts":[[2026,8]]}},"alternative-id":["diagnostics16152445"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics16152445","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,3]]}}}