Volpara Imaging Software

by Lunit  · Based in New Zealand → — Conquer Cancer Through Cutting-Edge AI. Smarter. Faster. Together.
General Surgery Oncology Radiology

Regulatory Status Disclosed

Overview

Volpara Health Technologies Limited provides an advanced AI software platform designed to revolutionize breast cancer screening and early detection. Their suite of products leverages artificial intelligence to offer comprehensive solutions for breast imaging analytics, risk assessment, and quality improvement. The software aids healthcare providers in objectively quantifying volumetric breast density, assessing mammography image quality (including positioning, compression, and dose), and evaluating individual patient cancer risk using models like Tyrer-Cuzick and Gail.

Volpara’s solutions are integrated into clinical workflows to streamline mammography reporting, patient tracking, and communication. They support regulatory compliance, such as MQSA, and offer performance analytics and benchmarking tools to help facilities optimize operations and enhance technologist skill development. The platform is designed to integrate with electronic health record systems, mammography reporting systems, imaging hardware, and genetic laboratories, providing a holistic approach to personalized breast care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered image analysis for breast tissue quantification
  • Volumetric breast density assessment (VolparaDensity)
  • Mammography quality assessment (positioning, compression, dose) via Volpara Analytics and Live!
  • Breast cancer risk assessment (Tyrer-Cuzick v7/v8, Gail models) via Volpara Risk Pathways and Scorecard
  • Personalized screening strategies and clinical decision support
  • Automated mammography reporting and patient tracking (Volpara Patient Hub)
  • Workflow optimization and efficiency tools
  • MQSA compliance management and reporting (Volpara Quiver)
  • Integration with EHR, mammography reporting systems, imaging hardware, and genetic laboratories
  • Performance analytics and benchmarking for continuous quality improvement

Use Cases

  • Early detection and prevention of breast cancer
  • Implementing personalized breast cancer screening programs
  • Improving mammography image quality and technologist performance
  • Streamlining mammography reporting and patient communications
  • Ensuring regulatory compliance for breast imaging centers
  • Identifying patients eligible for adjunctive imaging or genetic testing based on risk

What Physicians Need to Know

Key Capabilities
Volpara Imaging Software offers AI-powered image analysis for breast density assessment, mammography quality (positioning, compression, dose), and breast cancer risk assessment. It provides volumetric breast density measurements, BI-RADS breast density categories, and personalized dose measures. The software also includes tools for continuous quality assurance and performance monitoring through dynamic, interactive dashboards, and offers real-time feedback to technologists on positioning and compression to improve image quality.
Clinical Utility
Volpara Imaging Software aims to improve early breast cancer detection by augmenting mammography quality and workflow, providing objective volumetric breast density assessment, and supporting personalized breast care. It helps radiologists confidently identify dense breasts, communicate effectively with patients, and comply with state laws regarding breast density notification. The software also assists in optimizing pressure during mammography exams to decrease discomfort and optimize screening outcomes, and helps facilities reduce and standardize patient dose. It can also help identify high-risk patients who might benefit from additional screening, such as ultrasound or MRI.
Integration Options
Volpara Imaging Software is designed for easy integration into existing workflows and is compatible with data from most digital mammography vendors. It can be deployed stand-alone or fully integrated with Electronic Health Record (EHR) systems, mammography reporting systems, imaging hardware, and genetic laboratories. The software integrates with standard reading environments (PACS) and Radiological Information Systems (RIS), and utilizes DICOM structured reports for output.
Compliance Status
Volpara Imaging Software has received multiple 510(k) clearances from the U.S. Food & Drug Administration (FDA) for its breast density assessment algorithm, with the initial clearance in 2010 and subsequent clearances for updated versions incorporating AI. It is also CE-marked, cleared by Health Canada, and the TGA (Australia). The software's metrics can help facilities comply with FDA's EQUIP inspection program and MQSA requirements.
Pricing Model
Volpara Health is sold as a subscription, often with a trial or demo available. Pricing can be based on the number of analyses, installations, or users.
User Experience
The software provides objective information to radiologists and offers automated, objective assessment of image quality for technologists. Volpara Live! provides fast, on-the-job feedback to technologists to optimize positioning and compression, supporting continuous skill development and consistent imaging outcomes. Patient screening letters can include visual representations of breast density, improving patient understanding and compliance with recommendations.
Support Quality
Volpara offers monitoring, servicing, and updates for its software, facilitated by its Open Virtual Appliance (OVA) architecture.
Implementation Complexity
Volpara software products are integrated via a Virtual Appliance. Installation involves downloading and installing the Virtual Appliance in the virtual environment, followed by remote installation of Volpara software. Modifications to X-ray systems, PACS, and imaging workstations may be required, utilizing on-site resources.
Evidence Base
Volpara's technology is protected by 98 patents worldwide and is validated by more than 375 peer-reviewed publications and research abstracts. Studies have shown its volumetric density grades correlate strongly with mammography sensitivity and breast cancer risk. Research also indicates that using Volpara's AI to select women with extremely dense breasts for MRI in addition to mammography can reduce interval cancers. Volpara Analytics has been shown to improve image quality metrics and reduce technical repeats and recalls.
Physician Tip

Volpara Imaging Software provides objective, volumetric breast density measurements and BI-RADS categories, which can significantly aid in personalized breast cancer risk assessment and guide recommendations for supplemental screening. Leveraging the mammography quality assurance tools, particularly the real-time feedback for technologists, can lead to improved image quality and consistency across your facility, ultimately enhancing cancer detection. Utilize the patient-friendly density reports to improve patient understanding and engagement in their breast health journey. Remember that Volpara's density assessment is adjunctive information, and the final assessment of breast density category should be made by an MQSA-qualified interpreting physician.

Volpara Imaging Software is designed for multi-vendor compatibility with digital mammography and tomosynthesis units. It integrates seamlessly with existing PACS and RIS, and can also connect with EHR systems, mammography reporting systems, imaging hardware, and genetic laboratories. The use of DICOM structured reports facilitates data exchange. Ensure your facility's IT infrastructure, including virtual environments, meets the specifications for the Volpara Virtual Appliance for optimal performance and updates.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties General Surgery, Oncology, Radiology

What the Web Says

Volpara Imaging Software is an AI-powered platform designed to improve breast cancer screening and detection. It provides quantitative analysis of breast density, image quality, and cancer risk, aiming to enhance radiographer performance and aid physicians in personalized screening recommendations. The software integrates with existing healthcare systems like PACS and EHRs.

Overall: Positive

Strengths

  • Enhances mammography quality and radiographer performance through AI-driven feedback.
  • Provides objective, volumetric breast density assessment, reducing variability between readers.
  • Aids in earlier breast cancer detection and personalized screening pathways.
  • Integrates with various healthcare IT systems (PACS, DICOM, Epic, HL7 FHIR).
  • Offers a comprehensive platform including patient tracking, quality control, and risk assessment.
  • Backed by peer-reviewed research and holds regulatory approvals (FDA clearance, CE marking).

Limitations

  • Some employee reviews mention concerns about being overworked and underpaid, with poor management and low morale.
  • A scoping review noted that the evidence base is heavily centered on Volpara/TruPGMI™, raising concerns about generalizability and vendor bias.
  • The software is not an interpretive or diagnostic aid and should be used as adjunctive information.
  • Pricing changes often for AI tools, so current plans need to be checked directly with the vendor.

Based on reviews from: Indeed.com, Simpl.com, Saaskart, Imaging Technology News, PR Newswire, accessdata.fda.gov, Reddit, YouTube, Lunit, MDPI, AuntMinnie, Capterra, G2

Last updated: 2026-10-25

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Press & Coverage

Imaging Technology News
Volpara Now Operating Under Lunit Brand | Imaging Technology News
Volpara Health Technologies will now operate under the Lunit brand, unifying their strengths in breast health and AI innovation following Lunit's 2024 acquisition of Volpara. This integration creates a comprehensive ecosystem for cancer care, spanning risk prediction, early detection, imaging quality, and data-driven precision medicine.
2025-11
PR Newswire
Volpara Health Receives FDA Clearance for Next-Generation Breast Density Algorithm and Architecture - PR Newswire
Volpara Health received FDA clearance for Volpara Imaging Software (VIS 3.2), which enhances its breast density assessment algorithm with AI and expands compatibility to additional mammography machines from Giotto and Siemens. This marks the fifth FDA clearance for Volpara's key science algorithm since its initial clearance in 2010.
2021-07
Diagnostic Imaging
Volpara Receives FDA Clearance for Breast Density Algorithm | Diagnostic Imaging
Volpara Health announced FDA 510(k) clearance for Volpara Imaging Software (VIS 3.2), an AI-improved breast density assessment algorithm. The updated software also offers enhanced imaging processing security and broader compatibility with mammography machines from Giotto and Siemens.
2021-08
PR Newswire
Volpara Health Announces BOADICEA Integration and Record ECR 2025 Research Presence - PR Newswire
Volpara Health announced that its volumetric breast density assessment is now a validated input to the BOADICEA breast cancer risk model, in addition to Tyrer-Cuzick. This integration allows Volpara customers to utilize their density information via CanRisk, a tool endorsed by international societies.
2025-03
Health Informatics New Zealand
Kiwi digital health company sold for $300m - Health Informatics New Zealand
Wellington-based digital health company Volpara was acquired by South Korean firm Lunit for nearly $300 million NZD in 2024. This acquisition is expected to boost Lunit's AI-driven cancer diagnostics capabilities and expand Volpara's product offerings and global reach.
2024-07
Journal of Medical Screening
Breast density effect on the sensitivity of digital screening mammography in a UK cohort
A study published in July 2024 utilized Volpara Imaging Software (v.3.2.0) for automatic assessment of radiographic breast density in a UK cohort. The research aimed to analyze screening performance based on density categories and age groups, finding that interval cancer rates were highest in the densest categories.
2024-07
BioSpace
Volpara Health enters agreement to be acquired by Lunit, Inc. - BioSpace
Volpara Health Technologies announced an agreement to be acquired by Lunit Inc. for A$1.15 per share in cash. This acquisition aims to accelerate Volpara's mission of early breast cancer detection and leverage Lunit's AI expertise to expand product offerings and global market opportunities.
2023-12
FDA
Volpara Imaging Software 510(k) Summary - accessdata.fda.gov
This 510(k) summary details the Volpara Imaging Software, a software application intended for use with raw data from digital breast x-ray systems, including tomosynthesis, to provide volumetric assessment of breast density. The document confirms compliance with medical device standards and outlines the software's regulatory classification.
2018-08

Videos

Product demos, reviews, and walkthroughs for Volpara Imaging Software.

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Frequently Asked Questions

Volpara Imaging Software uses AI, specifically its TruDensity™ algorithm, to provide objective and volumetric breast density measurements from raw mammography images. This AI-powered analysis aids healthcare professionals in assessing breast tissue composition, identifying patients at higher risk for breast cancer, and guiding recommendations for additional imaging or genetic testing. The software also helps technologists optimize mammogram image quality, positioning, compression, and dose.
Volpara Imaging Software has received multiple 510(k) clearances from the U.S. Food & Drug Administration (FDA) since its initial clearance in 2010, with the latest version (VIS 3.2) incorporating AI to enhance its breast density assessment algorithm. It is intended for use as adjunctive information, meaning the final assessment of breast density category must be made by an MQSA-qualified interpreting physician. Volpara also offers Quiver™ software to help mammography centers manage compliance with the FDA's Mammography Quality Standards Act (MQSA).
Volpara Imaging Software is not an interpretive or diagnostic aid; it should only be used as adjunctive information for breast density assessment by an MQSA-qualified interpreting physician. While it provides volumetric breast density, some studies have shown variations in density estimates when compared to other automated methods. Additionally, the software's ability to predict breast cancer risk in all scenarios, particularly for interval cancer, may require further research.
Several alternatives to Volpara Health exist for breast density and risk assessment. These include NovaMG PRO, which offers an integrated mammography viewer with AI to improve efficiency and reduce false negatives, and WRRisk by Whiterabbit.ai, which provides a digital personalized screening plan based on patient risk levels. Other AI-powered platforms like CureMetrix and Mamosis also aim to enhance disease detection and improve cancer survival rates through advanced image analysis.
Volpara Health is generally sold as a subscription, and pricing can vary. Common pricing models are based on factors such as the number of analyses performed, the number of installations, or the number of users. It's recommended to contact Volpara Health directly or check their website for current plans and to inquire about free trial or demo options.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-19 | First Added: 2026-04-19
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