IMVARIA is a software-as-medical-device (SaMD) company pioneering AI-driven digital biomarker solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease and reduce the need for invasive biopsy testing. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates its Digital Biomarker Lab with automated, machine-learning algorithm technology to transform clinical decision-making into data science. IMVARIA is based in Berkeley, CA.

IMVARIA offers FDA-authorized digital biomarker solutions including Fibresolve and ScreenDx, which use artificial intelligence to assist clinicians in the diagnosis and assessment of lung diseases such as idiopathic pulmonary fibrosis (IPF) and interstitial lung disease (ILD). Fibresolve has received FDA De Novo marketing authorization and CPT billing code adoption by the American Medical Association, marking significant advancements in AI-based healthcare technologies. ScreenDx has also received 510(k) clearance from the FDA for screening ILD automatically. Both tools aim to provide non-invasive, precise, and supplementary diagnostic information to support clinical decision-making and improve patient outcomes.

The company collaborates with leading institutions such as the Mayo Clinic to enhance AI digital biomarker technologies for cancer analysis, beginning with lung cancer. IMVARIA's founding team includes physicians and engineers from Google and Stanford University, ensuring strong clinical and technical expertise is central to its mission. The company supports biopharmaceutical partners by optimizing clinical trial patient stratification and identifying new biomarker opportunities for therapeutic development.