Digital Biomarker Lab
Automated machine-learning platform for transforming clinical decision-making into data science
Company profile
Company profile
IMVARIA Inc. is a health technology company pioneering AI-driven digital biomarker solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease while reducing 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 flagship product, Fibresolve, received FDA De Novo marketing authorization in January 2024 as the first FDA-authorized diagnostic tool in lung fibrosis and the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association. Fibresolve uses artificial intelligence to guide safe, non-invasive diagnosis of lung fibrosis with a focus on idiopathic pulmonary fibrosis (IPF), serving as an adjunct to clinicians in assessing patients with suspected lung fibrosis to provide diagnostic subtype classification. IMVARIA has established a collaboration with Mayo Clinic through a know-how agreement to develop AI designed to improve the analysis and understanding of cancer, beginning with lung cancer. This partnership combines IMVARIA's engineering expertise in digital biomarkers with Mayo Clinic's data assets to discover and validate clinically relevant software-only biomarkers that analyze complex text, numeric values, and medical images. The company is based in Berkeley, California, and continues to advance digital healthcare delivery capabilities through its innovative AI-powered precision medicine approach.
Company description Imvaria, Inc official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Company milestones
FDA De Novo Marketing Authorization for Fibresolve (January 2024) - first FDA-authorized diagnostic tool in lung fibrosis; FDA Breakthrough Device Designation; AMA adoption of novel CPT billing codes (2024); Mayo Clinic collaboration announced (November 2023); Four presentations at ATS 2023 International Conference (May 2023)
Partnerships
02 · Flagship portfolio
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Automated machine-learning platform for transforming clinical decision-making into data science
FDA-authorized AI biomarker for non-invasive diagnosis of lung fibrosis and idiopathic pulmonary fibrosis
03 · Research intelligence
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Research
Respiratory investigation · Mar 1, 2026
Automated artificial intelligence detection of early or under-diagnosed interstitial lung disease by computed tomography in the COPDGene trial.Respiratory medicine · Dec 1, 2025
Multi-modal machine learning classifier for idiopathic pulmonary fibrosis predicts mortality in interstitial lung diseases.Respiratory investigation · Sep 1, 2025
ScreenDx, an artificial intelligence-based algorithm for the incidental detection of pulmonary fibrosis.The American journal of the medical sciences · Jun 1, 2025
Machine learning classifier is associated with mortality in interstitial lung disease: a retrospective validation study leveraging registry data.BMC pulmonary medicine · May 23, 2024
External validation of Fibresolve, a machine-learning algorithm, to non-invasively diagnose idiopathic pulmonary fibrosis.The American journal of the medical sciences · Mar 1, 2024
Clinical validation
No linked records are currently available.
Regulatory
K252041 · 510k · Nov 7, 2025
ScreenDxK241891 · 510k · Jan 10, 2025
FibresolveDEN220040 · De Novo · Jan 12, 2024
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Reduces need for invasive biopsy testing in lung fibrosis
CT-based machine learning classifier predicts mortality in interstitial lung diseases
Enables accurate diagnoses and prognoses at earlier stages of disease
Provides diagnostic subtype classification for lung fibrosis patients
Collaboration to develop AI designed to improve analysis and understanding of cancer, beginning with lung cancer, using large-scale datasets for comprehensive training of AI models to discover and validate clinically relevant software-only biomarkers
05 · Leadership
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06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies using AI, machine learning, or computational biology to discover new drug candidates, identify drug targets, predict drug efficacy, or accelerate pharmaceutical development. Includes both small molecule and biologics development, precision oncology drug discovery, and AI-driven target identification and molecule design.
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