IMVARIA Reports Multi-Site Clinical Experience With FDA-Authorized AI Diagnostic Service for Idiopathic Pulmonary Fibrosis at ATS 2025
IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today reported results from multi-site clinical experiences with IMVARIA’s diagnostic referral service, where pulmonologists send cases for AI-supported diagnostic evaluation of suspected Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF). Built by medical doctors with software engineering expertise, Fibresolve is the first ever FDA-authorized AI adjunctive diagnostic service of any type in lung fibrosis. Clinical data from use around the U.S. will be presented by pulmonary experts from Harvard’s Mass General Hospital at ATS 2025 International Conference, focusing on respiratory diseases, held on May 16-21, 2025 in San Francisco.
IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease
IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced its second FDA authorization, securing 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ScreenDx solution, an AI-powered healthcare tool to assist clinicians in assessing for interstitial lung disease (ILD).
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 Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the use of Fibresolve, a digital biomarker solution that uses artificial intelligence (AI) to guide safe, non-invasive diagnosis of lung fibrosis with a focus on idiopathic pulmonary fibrosis (IPF). This signifies the first ever FDA authorization of a diagnostic tool of any type in lung fibrosis, and the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association (AMA) in any disease.
IMVARIA Enters into Know-how Agreement with Mayo Clinic to Improve the Understanding of Cancer through AI Digital Biomarkers
IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced a collaboration through a know-how agreement with Mayo Clinic to develop AI designed to significantly improve the analysis and understanding of cancer, beginning with lung cancer. With its unique platform built by a cohort of co-founders to include former Googlers, engineers, and medical doctors, IMVARIA’s team of experts specializes in developing and advancing digital biomarkers to enable better patient outcomes.
IMVARIA Announces Data Demonstrating Company’s Non-Invasive Digital Biomarker for Predicting Mortality in Interstitial Lung Diseases
IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced data from a study evaluating the company’s lead non-invasive digital biomarker Fibresolve showing the tool’s supplemental ability to predict mortality in patients with interstitial lung disease (ILD). The results will be presented on May 24 as an oral presentation at the Mini Symposium “Looking for the Crystal Ball: Biomarkers to Predict Disease Progression and Mortality in ILD” at the American Thoracic Society 2023 International Conference (ATS 2023) in Washington, DC.
