IMVARIA
IMVARIA is a Berkeley-based SaMD company that uses AI to analyze CT scans and clinical data for non-invasive diagnosis of interstitial lung disease, idiopathic pulmonary fibrosis, and lung cancer, serving pulmonologists, health systems, and biopharma clients through its FDA-authorized Fibresolve, ScreenDx, and investigational Bronchosolve products.
- Company typePrivate
- Founded2019
- HeadquartersBerkeley, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What IMVARIA does
IMVARIA Inc. is a Berkeley, California-based software-as-medical-device (SaMD) company founded in 2019 that commercializes AI-driven digital biomarker diagnostics for serious lung disease. The company operates a centralized, cloud-based Digital Biomarker Lab—functionally analogous to a specialty CLIA lab but analyzing imaging and clinical data rather than biospecimens—where clinicians submit CT scans and clinical information for AI analysis and receive reports within minutes. IMVARIA is ISO 13485 certified and HIPAA compliant, and serves pulmonologists, health systems, life sciences companies, and patients with suspected interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), and lung cancer.
The company's product portfolio centers on three AI diagnostic tools. Fibresolve, the lead product, received FDA De Novo marketing authorization in January 2024 as the first FDA-authorized diagnostic of any type in lung fibrosis, and the first Breakthrough-Designated AI diagnostic with simultaneously adopted AMA Category III CPT billing code (0880T). ScreenDx received FDA 510(k) clearance in January 2025 as the first AI technology authorized to assess interstitial lung findings compatible with ILD. Bronchosolve, an investigational non-invasive lung cancer diagnostic, met primary endpoints in the pivotal VIRTUAL-BRONCH study in October 2025 and is advancing toward FDA submission. The underlying platform combines computer vision over CT imaging with multi-modal clinical data (text and structured values) to produce diagnostic subtype classifications and mortality predictions, trained on thousands of tissue-pathology-confirmed cases and augmented by a data collaboration with Mayo Clinic Platform.
IMVARIA generates revenue primarily through transaction-based diagnostic testing fees billable under CPT 0880T, complemented by professional services revenue from biopharma and clinical trial sponsors that use the platform for risk stratification and trial enrollment. Go-to-market combines direct enterprise sales to pulmonologists and health systems, channel partnerships (Medical Horizons for MENA, Viz.ai for U.S. health system distribution), and conference-driven clinical engagement (ATS, CHEST). The company has raised strategic capital from InHealth Ventures, Labcorp Venture Fund, Cedar Crest Holdings, Creative Ventures, and Meridian Street Capital, and was awarded a Phase I NIH SBIR grant to extend the platform into oncology.
IMVARIA firmographics
Firmographics- Name
- IMVARIA
- Legal name
- IMVARIA Inc.
- Website
- https://imvaria.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- IMVARIA is a Berkeley-based SaMD company that uses AI to analyze CT scans and clinical data for non-invasive diagnosis of interstitial lung disease, idiopathic pulmonary fibrosis, and lung cancer, serving pulmonologists, health systems, and biopharma clients through its FDA-authorized Fibresolve, ScreenDx, and investigational Bronchosolve products.
- Ownership category
- akta.pro rank
IMVARIA industry classification
Industry- Product category
- AI Medical Imaging Diagnostics
- NAICS
- Medical Laboratories (621511)
- SIC
- Services-Medical Laboratories (8071)
- akta.pro primary industry
- Medical Imaging AI (HDAAAEAH)
- akta.pro secondary industries
- Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO), Interstitial Lung Disease (ILD) & Pulmonary Fibrosis Care (HLAKANAF), Lung Cancer Screening & Pulmonary Nodule Clinic (HLAKANAI), Pulmonary Function Testing (PFT) & Respiratory Diagnostics (HLAKANAC)
Keywords
Where IMVARIA is headquartered
LocationHeadquarters
- HQ city
- Berkeley
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
IMVARIA business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Diagnostic Testing Services: IMVARIA generates revenue through its AI-powered diagnostic testing services. Clinicians order Fibresolve and ScreenDx tests through IMVARIA's centralized service, submitting CT scans and clinical data for AI analysis. Results are returned to the ordering clinician. The service is billable using Category III CPT code 0880T for test result interpretation, making it practical for clinicians to incorporate into medical practice. The company works with insurance companies and has financial assistance programs for individuals.
- Life Sciences / Clinical Trial Services: IMVARIA offers its AI biomarker technology to biopharma partners and clinical trialists for optimizing study enrollment, risk-stratifying patients at trial enrollment, and developing predictions for treatment response. This represents a B2B revenue stream serving the pharmaceutical and clinical research market.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Transaction based/ take rate | Pay-as-you-go | Fibresolve diagnostic test for ILD/IPF assessment |
Go-to-market motion4 records
Distribution channels3 records
Marketing channels5 records
IMVARIA product offering
Product offeringCore offering
IMVARIA provides AI-driven digital biomarker diagnostic services that analyze lung CT imaging and clinical data through a centralized cloud-based Digital Biomarker Lab. Its commercial products include Fibresolve (FDA De Novo authorized for adjunctive diagnosis of ILD/IPF), ScreenDx (FDA 510(k) cleared for automated ILD screening), and the investigational Bronchosolve (non-invasive pulmonary nodule/lung cancer assessment). Clinicians and health systems submit cases and receive AI-generated diagnostic subtype classifications in minutes, billable under Category III CPT code 0880T.
Product overview
IMVARIA is a Software-as-Medical-Device (SaMD) company offering AI-driven digital biomarker solutions through a centralized diagnostic service model. The core product portfolio includes three distinct AI diagnostic tools: Fibresolve (FDA De Novo authorized, January 2024) for adjunctive diagnosis of ILD and IPF; ScreenDx (FDA 510(k) cleared, January 2025) for automated ILD screening; and Bronchosolve (investigational, pivotal study completed October 2025) for lung cancer diagnosis in suspicious pulmonary nodules. All products analyze CT imaging data using proprietary machine learning algorithms without requiring invasive procedures. Clinicians access these services through IMVARIA's centralized cloud-based AI Lab by submitting cases via a web order portal, with results returned within minutes. The platform also includes a financial assistance program and Category III CPT billing codes for reimbursement.
Differentiator
Problem solved
Functional benefit
Brands
- Fibresolve: FDA-authorized AI diagnostic service for interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) assessment using non-invasive CT scan analysis
- ScreenDx
- Bronchosolve
- Digital Biomarker Lab
Products and services
- Fibresolve FDA-authorized AI diagnostic service that uses fully automated machine learning and non-invasive CT scans of the lungs to provide diagnostic subtype classification of interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF), serving as an adjunct to clinicians prior to invasive testing.
- ScreenDx FDA 510(k)-cleared AI-powered screening algorithm that automatically assesses CT scans for interstitial lung findings compatible with ILD, operating as a background-only technology to enhance referral workflows without requiring technologist operation.
- Bronchosolve Investigational AI-powered diagnostic solution for the assessment of suspicious pulmonary nodules and non-invasive lung cancer diagnosis; a fully automated end-to-end platform designed for improved classification of indeterminate lung nodules.
- AI Lab (Digital Biomarker Lab) Centralized, cloud-based digital lab operating like a specialty CLIA lab but handling data rather than physical samples; clinicians and biopharma clients transmit cases and receive AI analysis reports in minutes, supporting multiple imaging modalities (CT, MRI) and data types under ISO 13485 quality compliance.
Quantifiable outcome
- IPF diagnoses increased by >3x in challenging ILD and IPF cases in the pre-invasive setting
- +3 more outcomes
Companies that use IMVARIA
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles2 records
IMVARIA technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability7 records
Feature4 records
IMVARIA partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- Viz.aicoreIMVARIA partnered with Viz.ai, the leader in AI-powered disease detection and care coordination, in November 2025. This collaboration expands Viz.ai's pulmonary portfolio and introduces new AI capabilities that can assess for interstitial lung findings compatible with ILD. Viz.ai has existing relationships with health systems using its care coordination software.
- Medical HorizonscoreIMVARIA announced a strategic distribution partnership with Medical Horizons, a premier AI-powered medical device distributor based in Florence, Italy, to expand presence in the MENA (Middle East and North Africa) region. Medical Horizons' extensive sales network and expertise in cloud-based healthcare solutions provides a strong foundation for accelerating adoption of IMVARIA's technology among pulmonologists. The company has a proven track record with installations at renowned centers including Campus Biomedico Roma, Meyer Labs Florence, Sant' Andrea Roma, and Gruppo Multimedia Milano.
- Mayo CliniccoreIMVARIA entered into a know-how agreement with Mayo Clinic to develop AI designed to significantly improve the analysis and understanding of cancer, beginning with lung cancer. The collaboration brings together IMVARIA's engineering expertise in digital biomarkers with Mayo Clinic's know-how and data assets as part of the Validate pillar of Mayo Clinic Platform. Large-scale datasets enable comprehensive and reliable training of AI models to discover and validate clinically relevant software-only biomarkers.
Scale indicators7 records
Recent moves10 records
Expansion highlights7 records
IMVARIA competitors and assessment
Company assessmentDirect peers
- Optellum: Optellum is an AI lung-health company whose Virtual Nodule Clinic and lung-cancer prediction platform analyze CT imaging for pulmonary nodules — directly comparable to IMVARIA's Bronchosolve product and adjacent to its lung-disease focus.
- Aidoc: Aidoc develops clinical AI algorithms that analyze medical imaging across multiple specialties and integrate into radiologist workflows, making it a comparable AI-imaging-diagnostics peer (broader portfolio than IMVARIA but overlapping target customers and use cases).
- Arterys: Arterys offers cloud-based AI medical imaging analytics with FDA-cleared products across multiple modalities — comparable to IMVARIA as a cloud-delivered AI imaging diagnostics company pursuing similar enterprise health-system customers.
- Riverain Technologies: Riverain Technologies develops AI algorithms for chest CT and X-ray analysis with a long-standing focus on lung and thoracic imaging — directly comparable to IMVARIA's Fibresolve and ScreenDx products targeting ILD, IPF, and lung findings.
- Perspectum: Perspectum develops AI-powered imaging diagnostic services (notably for liver disease) delivered through a centralized digital lab model — directly comparable to IMVARIA's Digital Biomarker Lab model and SaMD commercial approach.
- Quibim: Quibim provides AI-powered medical imaging analysis across multiple organ systems as a SaaS/diagnostics platform for hospitals and clinical trials — overlapping with IMVARIA in AI imaging diagnostics for enterprise health systems and life sciences customers.
Broad incumbents
- Viz.ai: Viz.ai is the leader in AI-powered disease detection and care coordination, and is both a partner of IMVARIA (post-Nov 2025) and a broader AI-imaging incumbent whose pulmonary and radiology workflow tools compete for the same health-system budgets.
- Tempus Labs: Tempus is a large AI-driven precision medicine platform combining clinical and molecular data for diagnostics and biopharma research — broader than IMVARIA but overlapping in the AI diagnostic and biopharma/clinical-trial services business model.
Emerging players
- Anumana: Anumana is an AI-driven SaMD company developing ECG-based diagnostics for cardiology, backed by Mayo Clinic — comparable to IMVARIA as a physician-engineer-led SaMD commercializing AI diagnostics through FDA pathways and clinical partnerships.
- Paige.AI: Paige builds AI-driven digital diagnostics with FDA-authorized products for pathology and oncology — comparable to IMVARIA as a clinical AI diagnostics company pursuing FDA-authorized SaMD in cancer-adjacent specialties.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
IMVARIA social profiles
Digital presenceIMVARIA compliance and trust
Trust signalCompliance2 records
IMVARIA financial estimates
Financial estimateRevenue estimate
Valuation estimate
IMVARIA leadership team
Management profileNumber of profiles
Profiles3 records
IMVARIA funding detail
Funding detailFunding overview
Funding rounds4 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
IMVARIA M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about IMVARIA
What does IMVARIA do?
IMVARIA provides AI-driven digital biomarker diagnostic services that analyze lung CT imaging and clinical data through a centralized cloud-based Digital Biomarker Lab. Its commercial products include Fibresolve (FDA De Novo authorized for adjunctive diagnosis of ILD/IPF), ScreenDx (FDA 510(k) cleared for automated ILD screening), and the investigational Bronchosolve (non-invasive pulmonary nodule/lung cancer assessment). Clinicians and health systems submit cases and receive AI-generated diagnostic subtype classifications in minutes, billable under Category III CPT code 0880T.
Is IMVARIA a public or private company?
IMVARIA is a private company. It is classified as venture growth investor backed and is currently operating.
When was IMVARIA founded?
IMVARIA was founded in 2019. It employs 11 to 50 people.
Where is IMVARIA based?
IMVARIA is headquartered in Berkeley, United States, in the North America region.
How does IMVARIA make money?
Two revenue lines are on record. Diagnostic Testing Services are the primary driver. The others are life Sciences / Clinical Trial Services.
Who are IMVARIA's main competitors?
Direct peers on record are Optellum, Aidoc, Arterys, Riverain Technologies, Perspectum and Quibim. Broad incumbents are Viz.ai and Tempus Labs. Emerging players are Anumana and Paige.AI.
Does IMVARIA have an API?
No public API is recorded for IMVARIA.
What industry is IMVARIA in?
IMVARIA's product category is AI Medical Imaging Diagnostics. Its primary akta.pro industry code is HDAAAEAH, Medical Imaging AI, with a secondary code of HLAAALAO, Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays). Its NAICS code is 621511 and its SIC code is 8071.