Volpara Imaging Software

by Volpara Health Technologies Limited  · Based in New Zealand → — Clinically validated, AI-powered software for personalized screening and early detection of breast cancer.
General Surgery Oncology Radiology
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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

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-based (Microsoft Azure)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Volpara Imaging Software (VIS) has received multiple FDA clearances since 2010, including for its breast density assessment algorithm (VIS 3.2) and for correlation to BI-RADS 4th and 5th Edition categories.
Integrations
EHR Not specified
Specialties General Surgery, Oncology, Radiology

What the Web Says

Volpara Imaging Software is widely recognized in the healthcare industry, particularly in breast cancer screening, for its AI-powered solutions that enhance mammogram quality and provide objective breast density assessments. Physicians and technologists praise its ability to reduce technical repeats and recalls, streamline workflows, and improve the accuracy of risk assessments. The software is used in numerous facilities globally and is supported by a significant number of peer-reviewed studies.

Overall: Positive

Strengths

  • Enhances mammogram image quality and consistency through AI-driven feedback to technologists.
  • Provides objective and volumetric breast density assessment, reducing inter and intra-observer variability among radiologists.
  • Aids in more accurate breast cancer risk assessment and personalized screening recommendations.
  • Reduces technical repeats and recalls significantly, improving efficiency and patient experience.
  • Integrates with EMRs and other imaging systems, offering flexible deployment options.
  • Backed by a large number of peer-reviewed scientific papers, demonstrating clinical validation.

Limitations

  • Some employee reviews mention issues with management, lack of training, and feeling overworked.
  • The software is not a diagnostic aid and should be used as adjunctive information by a qualified physician.
  • Competitors also offer strong AI solutions for breast cancer detection and risk assessment.

Based on reviews from: Slashdot, Indeed.com, PR Newswire, Microsoft Unlocked, Lunit, Mucrama (Reddit), Imaging Technology News, YouTube (Allevia Radiology), Reddit (r/ausstocks), accessdata.fda.gov

Last updated: 2026-07-19

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Press & Coverage

PR Newswire
Volpara Health Receives FDA Clearance for Next-Generation Breast Density Algorithm and Architecture
Volpara Health received FDA clearance for Volpara Imaging Software (VIS 3.2), which enhances its breast density assessment algorithm with AI and expands compatibility with additional mammography machines. This marks Volpara's fifth FDA clearance for its core algorithm since 2010, supporting its integrated Volpara Breast Health Platform.
2021-07
Diagnostic Imaging
Volpara Receives FDA Clearance for Breast Density Algorithm
Volpara Health announced FDA 510(k) clearance for Volpara Imaging Software (VIS 3.2), an AI-powered update to its breast density assessment algorithm. The new version also improves image processing security and expands support for Giotto and Siemens mammography units.
2021-08
AuntMinnie
Volpara nets new FDA clearance
Volpara Solutions secured FDA clearance for version 3.2 of its Volpara Imaging Software (VIS), which incorporates AI to improve breast density assessment and extends compatibility to more mammography systems from IMS Giotto and Siemens Healthineers. The clearance also includes the Open Virtual Appliance (OVA) architecture for enhanced security and easier software updates.
2021-07
Imaging Technology News
Volpara Health Receives FDA Clearance for Next-Generation Breast Density Algorithm and Architecture
Volpara Health has received FDA clearance for Volpara Imaging Software (VIS 3.2), an advanced AI-powered algorithm for breast density assessment. This clearance enhances the robustness of the algorithm, expands its use to additional mammography machines, and introduces an Open Virtual Appliance (OVA) architecture for improved security and scalability.
2021-07
JNCI: Journal of the National Cancer Institute
Cost-Effectiveness of Magnetic Resonance Imaging Screening for Women With Extremely Dense Breast Tissue
A study published in the Journal of the National Cancer Institute indicates that MRIs are cost-effective for detecting breast cancer in women with extremely dense breast tissue, with Volpara Imaging Software used to measure breast density (Volpara density grade 4) in the DENSE trial.
2021-09
Imaging Technology News
Volpara Now Operating Under Lunit Brand
Volpara Health Technologies will now operate under the Lunit brand, following Lunit's 2024 acquisition of Volpara. This rebranding unifies their strengths in breast health and AI innovation, aiming to create a comprehensive ecosystem for cancer diagnostics and precision oncology.
2025-11
BioWorld
Lunit to acquire Volpara for $193M, targeting US breast cancer market
AI software developer Lunit Inc. plans to acquire Volpara Health Technologies Ltd. for $193 million by mid-2024, aiming to expand its presence in the U.S. breast cancer market. Volpara's AI-powered mammography solutions are operational in over 2,000 U.S. medical sites.
2023-12
Medical Device Network
Lunit to acquire Volpara Health Technologies for $193m
Medical AI company Lunit has signed an agreement to acquire Volpara Health Technologies for approximately A$292m ($193m), with the deal expected to be completed in the second quarter of next year. Volpara provides software for the early detection of breast cancer, and this acquisition will enhance Lunit's capabilities in cancer diagnostics.
2023-12

Videos

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

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Frequently Asked Questions

Volpara's AI utilizes computer vision and deep learning to provide objective, volumetric breast density assessment, image quality analytics, and positioning metrics, aiming to support radiologists rather than replace their clinical judgment. Its primary applications include enhancing personalized cancer screening, risk assessment, and improving mammogram quality by identifying areas for technologist improvement.
Volpara Imaging Software is FDA cleared and CE marked, demonstrating its adherence to medical device regulations. It is also HIPAA compliant, supports MQSA, ACR BI-RADSu00ae, and NQMBC, ensuring robust data privacy, security, and quality assurance in its AI-driven processes.
Volpara's AI aims to reduce the significant reader variability and inconsistency inherent in visual breast density assessment by providing standardized, reproducible volumetric measurements. By analyzing raw images, it ensures more consistent and accurate breast density assessments, mitigating distortions that can arise from varied image processing across different vendors.
While Volpara's AI is highly validated, it is an adjunctive tool and not intended for primary diagnosis, with final assessment remaining with an MQSA-qualified physician. Studies have shown a potential bias against acting solely on AI findings, even when accurate, which Volpara addresses by emphasizing its role in supporting, not replacing, clinical judgment and building trust through extensive validation.
Volpara's pricing typically follows a subscription model or is based on factors such as the number of analyses, installations, or users. While specific pricing details are proprietary, this model is common among advanced healthcare AI solutions, which often require significant investment due to their complex development, extensive validation, and continuous improvement.
Several other AI solutions exist in the breast imaging market that physicians might consider. These include CureMetrix, NovaMG PRO by Novarad, WRRisk from Whiterabbit.ai, Mamosis, and Lunit INSIGHT, which recently acquired Volpara Health. These alternatives often focus on similar areas like cancer detection, risk assessment, and workflow efficiency.
Volpara ensures continuous improvement by analyzing a vast and diverse dataset of over 50 million images and cases from facilities worldwide, which helps refine its algorithms. This extensive data, combined with its use of raw image data, makes its AI robust and generalizable across various mammography systems, breast compositions, and image processing algorithms.

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