Linked research, clinical, and regulatory source pathways.
Company profile
About Volpara Health
Lunit is a global medical AI company transforming cancer detection and treatment through cutting-edge artificial intelligence. The company operates across two primary domains: cancer screening and precision oncology. In cancer screening, Lunit offers an integrated ecosystem including Lunit INSIGHT MMG for 2D mammography, Lunit INSIGHT DBT for 3D tomosynthesis, and Lunit INSIGHT CXR for chest X-ray analysis, alongside complementary tools for density assessment, risk stratification, quality management, and patient engagement. In precision oncology, Lunit SCOPE provides AI-powered pathology solutions for tumor microenvironment analysis, IHC biomarker quantification (including HER2 and PD-L1), and genotype prediction to accelerate drug development and companion diagnostics. The company's technology is built on millions of expertly annotated images from diverse global datasets and is designed for seamless integration into clinical workflows through partnerships with leading imaging manufacturers and PACS/RIS vendors. With FDA clearance and CE certification under MDR, Lunit's solutions are deployed at over 10,000 customer sites across 65+ countries, supported by 700+ peer-reviewed publications and 100+ strategic partnerships. The company serves radiologists, health systems, biopharma companies, and research institutions, working toward a future where cancer is detected earlier and treated with greater precision for improved patient outcomes.
Company description Volpara Health official website
Primary marketMedical Imaging & Radiology
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Breast cancer
- HER2
- Lung abnormalities
- PD-L1
- Tumor microenvironment analysis
- Various oncology biomarkers
Who it serves
- Biopharma companies
- Clinical trial sites
- Health Systems
- Hospitals
- Radiology practices
- Research institutions
Deployment & integration
Deployment information is currently being developed.
Recorded integration context: Digital health platforms, EHR systems, Imaging system manufacturers, PACS/RIS vendors.
Geographic context
MarketsBrazil · Global - 65+ countries · Kingdom of Saudi Arabia · South Korea · United Kingdom · United States
Company sourceOfficial website
Company milestones
Platform expansion
Surpassed 330+ sites and 1M annual screenings for breast imaging AI. Presented six AI studies at AACR 2026. Highlighted IHC and tumor microenvironment research at ASCO 2026. Selected as AI medical system supplier for regional responsibility medical institutions in Korea.
Partnerships
Recorded partners
- 100+ partnerships with imaging manufacturers
- Digital health platforms
- Dr. Sulaiman Al Habib Medical Group
- Global biopharma companies
- PACS/RIS vendors
- Prevent Senior Hospital
- Sol Radiology
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
No source-backed Company products are currently listed.
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Mammographic Density in Relation to Breast Cancer Risk Factors among Chinese Women.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · Feb 6, 2025
Associations between quantitative measures of mammographic density and terminal ductal lobular unit involution in Chinese breast cancer patients.Breast cancer research : BCR · Jul 15, 2024
Reproductive risk factors for breast cancer and association with novel breast density measurements among Hispanic, Black, and White women.Breast cancer research and treatment · Apr 1, 2024
Joint AAPM Task Group 282/EFOMP Working Group Report: Breast dosimetry for standard and contrast-enhanced mammography and breast tomosynthesis.Medical physics · Feb 1, 2024
Impact of Artificial Intelligence-driven Quality Improvement Software on Mammography Technical Repeat and Recall Rates.Radiology. Artificial intelligence · Nov 1, 2023
Quantitative Breast Density in Contrast-Enhanced Mammography.Journal of clinical medicine · Jul 27, 2021
Clinical validation
Clinical-trial records
No linked records are currently available.
Regulatory
Regulatory records
Volpara Imaging SoftwareK211279 · 510k · Jul 27, 2021
Volpara Imaging SoftwareK182310 · 510k · Sep 21, 2018
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
10,000+ customer sites
Global deployment scale
1M+ annual screenings
Breast imaging AI in clinical practice
65+ countries
Geographic reach
700+ publications
Clinical evidence base
Improved cancer detection
Finding smallest cancers not previously detected
Reduced reading fatigue
3D tomosynthesis review efficiency
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from Volpara Health
Recent articles published on Volpara Health'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
Medical Imaging & Radiology
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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