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.
The company's lead product, Fibresolve, received FDA De Novo marketing authorization in January 2024 as the first FDA-authorized diagnostic tool in lung fibrosis. Fibresolve is an AI-powered digital biomarker solution that helps guide safe, non-invasive diagnosis of lung fibrosis with a focus on idiopathic pulmonary fibrosis (IPF).
Based in Berkeley, CA, IMVARIA is also using its technology to support biopharmaceutical partners through optimizing pre-trial patient stratification and identifying new AI biomarker opportunities for therapeutics development.