IMVARIA Inc.

IMVARIA is a software-as-medical-device (SaMD) company that develops AI-driven digital biomarker solutions for clinical decision support, with a primary focus on non-invasive diagnosis of pulmonary and oncological diseases. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates an AI Lab with automated machine-learning algorithm technology to analyze computed tomography (CT) imaging and clinical data. The company's lead FDA-authorized product, Fibresolve, received FDA De Novo marketing authorization in January 2024 as the first FDA-authorized diagnostic tool for lung fibrosis, specifically idiopathic pulmonary fibrosis (IPF). Fibresolve also holds the distinction of being the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association. It analyzes lung CT imaging to provide diagnostic subtype classification for suspected interstitial lung disease (ILD), serving as an adjunct to clinician assessment and reducing the need for invasive biopsy testing. In January 2025, IMVARIA received FDA 510(k) clearance for ScreenDx, a screening algorithm designed to assess for interstitial lung disease findings on CT imaging. This tool assists with early identification and referral pathways for suspected ILD across diverse clinical settings including emergency departments and lung cancer screening programs. The company is also developing Bronchosolve, an investigational AI-powered diagnostic solution for assessment of suspicious pulmonary nodules in lung cancer cases. In October 2025, Bronchosolve met primary endpoints in the pivotal VIRTUAL-BRONCH Study, demonstrating improved accuracy in non-invasive lung cancer diagnosis. IMVARIA received Phase I NIH SBIR grant funding in September 2025 to extend its AI platform into oncology. IMVARIA operates a centralized service model requiring minimal workflow disruption for clinicians. The company has established clinical partnerships with Mayo Clinic and multiple U.S. medical institutions, and announced a strategic distribution partnership with Medical Horizons to expand access in the Middle East and North Africa region. All products are cloud-based, software-only solutions that integrate with existing CT imaging infrastructure.