Company profile

Imvaria, Inc

Drug Discovery & Development

Company profile

About Imvaria, Inc

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

Primary marketDrug Discovery & Development
Commercial modelCommercial information available on request
Company presenceOfficial website
Work at Imvaria, Inc?

Claim this profile to manage Company information and connect with the Health AI Central audience.

Claim this listing

01 · Operating footprint

Where the Company operates

Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.

Clinical focus

  • Idiopathic Pulmonary Fibrosis (IPF)
  • Interstitial Lung Diseases (ILD)
  • Lung Cancer
  • Lung Fibrosis

Who it serves

  • Clinicians
  • Healthcare providers
  • Medical research community

Deployment & integration

Cloud Saas deployment with recorded integration context.

Geographic context

MarketsUnited States
Company sourceOfficial website

Company milestones

Platform expansion

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

Recorded partners

  • Mayo Clinic (know-how agreement for cancer digital biomarkers)
  • Mayo Clinic Platform (Validate pillar)

02 · Flagship portfolio

Products, workflows, and platform capabilities

Selected source-backed Company products and the available commercial context.

Digital Biomarker Lab

Automated machine-learning platform for transforming clinical decision-making into data science

Platform · Cloud SaaSCompany source

Fibresolve

FDA-authorized AI biomarker for non-invasive diagnosis of lung fibrosis and idiopathic pulmonary fibrosis

Software · Cloud SaaSCompany source

03 · Research intelligence

Research Intelligence evidence

Publications, preprints, clinical validation, and regulatory records in Evidence Position order.

04 · Company-reported outcomes

Outcomes and case studies

Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.

Non-invasive diagnosis

Reduces need for invasive biopsy testing in lung fibrosis

Mortality prediction

CT-based machine learning classifier predicts mortality in interstitial lung diseases

Earlier diagnosis

Enables accurate diagnoses and prognoses at earlier stages of disease

Diagnostic subtype classification

Provides diagnostic subtype classification for lung fibrosis patients

Mayo Clinic

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

Leadership team

Leadership profiles and professional links from the current Company record.

06 · Company updates

Updates from Imvaria, Inc

Recent articles published on Imvaria, Inc's official website.

No Company updates are currently listed.

07 · HAIC coverage

Coverage and analysis

Health AI Central reporting that mentions this Company.

No HAIC coverage is currently linked to this Company.

08 · Official presence

Company sources and channels

Curated official destinations from the active Company record.

09 · Market pathway

Additional Companies in this Market

Other active Companies in the same market, selected alphabetically from the HAIC directory.

Market context

Drug Discovery & Development

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.

Explore the full market directory or compare this Company with additional active profiles.

View all Companies in this market

10 · Pro research

Coming soon

Expanded Company research is in development.

Health AI Central Pro · Coming Soon

Deeper Company research is coming soon.

Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.

ResearchEvidence analysis

Linked research, clinical, and regulatory source pathways.

CompanyTechnical context

Expanded product, deployment, integration, and partnership research.

MethodSource & review record

Record-level provenance and review context.

Coming Soon