QVCAD System

by QView Medical  · Based in United States → — AI-Powered Detection for 3D Breast Ultrasound Screening
Oncology Radiology

Custom
Regulatory Status Disclosed

Overview

The QVCAD System by QView Medical is an artificial intelligence-enabled computer-aided detection (CAD) software designed to assist in breast cancer screening. It is specifically developed for use with 3D Automated Breast Ultrasound (ABUS) systems to support the evaluation of asymptomatic women with dense breast tissue who have had negative mammograms.

Tailored for radiologists and breast imaging specialists in clinical and outpatient imaging settings, the system integrates directly into the diagnostic reading workflow. Unlike traditional CAD tools that function as a secondary look after the initial review, QVCAD is designed for concurrent reading. This allows physicians to view CAD-generated findings at the start of their image analysis, helping to streamline the review of complex, high-volume ABUS datasets.

Key capabilities of the system include:

  • C-Thru Navigator: An overview image that highlights potential regions of interest (ROIs) such as dark areas or architectural spiculations, allowing radiologists to assess the entire case quickly.
  • Interactive ROI Hovering: Users can hover over flagged regions to instantly display corresponding transverse and coronal views, facilitating rapid scrolling and detailed examination of adjacent slices.
  • Standardized Integration: The software receives native ABUS images via standard DICOM format and processes them using deep learning algorithms to distinguish potential lesions from normal tissue.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered Computer-Aided Detection (CAD)
  • Image processing software for 3D ABUS
  • Detects suspicious areas of breast tissue (5mm or more)
  • Utilizes sophisticated algorithms and artificial neural networks
  • Q-Viewer for concurrent display of ABUS images and CAD output
  • QVCAD Navigator image (C-Thruu2122 technology) for overview and highlighting abnormalities
  • Aids in reducing ABUS interpretation time by 33% while maintaining diagnostic accuracy
  • DICOM format input for images
  • Provides synthetic 2D images for quick overview
  • Enhances radial spiculations and retraction patterns in coronal reconstructions

Use Cases

  • Aid to radiologists during breast screening procedures
  • Screening women with dense breast tissue
  • Detection of mammography-occult lesions
  • Improving radiologist productivity and workflow for ABUS interpretation
  • Reducing interpretation time of screening ABUS exams
  • Supporting multi-modality breast screening protocols

What Physicians Need to Know

Key Capabilities
The QVCAD System is an AI-powered Computer-Aided Detection (CAD) and image processing software designed to aid radiologists in reading 3D Automated Breast Ultrasound (ABUS) images for women with dense breast tissue and negative mammograms. It utilizes deep learning algorithms and artificial neural networks to detect and highlight suspicious areas, distinguishing potential lesions from normal tissue. The system provides a 'C-thruu2122 Navigator image' with CAD marks (green circles) and a 'Hover Mode' for detailed review of regions of interest.
Clinical Utility
QVCAD is indicated as an aid for radiologists during breast screening procedures, particularly for women with dense breasts where mammography may be less effective. It significantly reduces ABUS interpretation time by an average of 33% while maintaining diagnostic accuracy. The system has been shown to increase cancer detection rates, with clinical trials indicating it can detect up to 35.7% more cancers than ABUS alone. It also helps shorten the learning curve for new ABUS users and enhances diagnostic confidence.
Integration Options
The QVCAD system receives input images via a standard DICOM format from ABUS acquisition systems or PACS. It is integrated with GE Healthcare's Inveniau2122 ABUS 2.0 system, allowing direct access to the software through the Invenia ABUS Viewer for a streamlined workflow. The system itself consists of a CAD engine and a Q-Viewer software package running on a customer-supplied workstation. The vendor has not publicly disclosed other third-party integrations or an API.
Compliance Status
QVCAD is the first FDA PMA-approved (Premarket Approval) CAD system for concurrent reading of 3D Automated Breast Ultrasound, receiving approval on November 9, 2016. It has also received the CE Mark for use with ABUS/ABVS systems. The device is restricted to prescription use, and its labeling must specify the required training or experience for practitioners.
Pricing Model
QView Medical offers a tailored pricing model for QVCAD, which can be customized based on a company's specific requirements and size. Specific pricing plans are not publicly disclosed, and interested parties are encouraged to request a personalized cost estimate.
User Experience
The system is designed to enhance radiologist productivity and reduce the time spent interpreting complex ABUS exams. The Q-Viewer provides a comprehensive platform for concurrently displaying ABUS images and CAD output. Its interactive features, such as the C-thruu2122 Navigator image and Hover Mode, facilitate efficient review and highlight areas of concern. This design aims to shorten the learning curve for new ABUS users and boost diagnostic confidence.
Support Quality
Installation and commissioning of the QVCAD System are exclusively performed by qualified QView Medical, Inc. personnel. Following installation, a comprehensive user training program is provided to instruct users on the system's operation.
Implementation Complexity
Implementation involves installation and commissioning by QView Medical personnel. The software runs on a customer-supplied workstation and requires integration with existing ABUS acquisition systems or PACS via a standard DICOM interface. While initial installations might have involved external hardware, the system now offers streamlined integration with GE Healthcare's Invenia ABUS Viewer.
Evidence Base
QVCAD's safety and effectiveness are supported by a pivotal clinical study that demonstrated improved productivity without compromising cancer detection performance. A reader study published in the American Journal of Radiology confirmed a 33% reduction in interpretation time while maintaining diagnostic accuracy. The underlying deep learning algorithms were trained on over 20,000 ABUS cases, including 3,000 biopsy-proven cancer cases. Clinical trials have shown QVCAD can detect up to 35.7% more cancers than ABUS alone.
Physician Tip

For radiologists utilizing ABUS for dense breast screening, QVCAD can significantly enhance workflow efficiency by reducing interpretation time by approximately one-third without compromising diagnostic accuracy. Leverage the C-thruu2122 Navigator image for a quick overview and utilize the 'Hover Mode' for rapid, detailed examination of suspicious areas. Remember that QVCAD is an aid, and the final diagnostic assessment remains with the physician. The system is particularly beneficial for new ABUS users to shorten their learning curve and increase confidence in interpreting complex volumetric data. Ensure proper training from QView Medical personnel to maximize the system's utility.

The QVCAD System is designed to integrate seamlessly with 3D Automated Breast Ultrasound (ABUS) systems, specifically GE Healthcare's Inveniau2122 ABUS 2.0, through its viewer for a streamlined workflow. It accepts DICOM-formatted images from ABUS acquisition systems or PACS. While direct integration with other third-party systems or a public API is not currently disclosed, its DICOM compatibility allows for standard image data exchange within a radiology department's existing infrastructure.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Custom — Custom pricing based on features and organizational requirements.
DeploymentOn-premise (behind hospital firewall)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The QVCAD System received Premarket Approval (PMA P150043) from the FDA on November 9, 2016. It is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (ABUS) to detect mammography-occult lesions in regions not known to have suspicious findings, specifically for women with screening mammography BI-RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d.

Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

The QVCAD System is an AI-powered, FDA-approved computer-aided detection (CAD) system for 3D Automated Breast Ultrasound (ABUS) screening, designed to assist radiologists in detecting breast cancer, particularly in women with dense breast tissue. It aims to improve diagnostic accuracy and significantly reduce the interpretation time of ABUS exams, which can involve up to 2,000 images per case. Physicians and researchers have highlighted its potential to become a new standard of care in breast ultrasound interpretation and to shorten the learning curve for new ABUS users.

Overall: Positive

Strengths

  • Reduces ABUS interpretation time by up to 33% while maintaining diagnostic accuracy.
  • Increases diagnostic confidence for radiologists, especially new ABUS users.
  • Aids in detecting suspicious areas in dense breast tissue, where mammography may be less effective.
  • Provides a C-thruu2122 Navigator image for an immediate visual overview of the entire ABUS case.
  • Highlights potentially malignant lesions with CAD marks and enhanced dark areas.
  • Streamlines clinical workflow through integration with ABUS systems.

Limitations

  • Interpretation of ABUS exams, even with QVCAD, can still be complex.
  • The reading time improvement primarily applies to the ABUS component, and overall productivity depends on other factors.
  • Some general concerns exist about AI systems in healthcare, such as potential for false positives and the need for unbiased data.
  • No specific cons from direct user reviews of QVCAD were found on G2, Capterra, or Reddit, which instead showed reviews for different CAD software (QCAD) or general AI in healthcare discussions.

Based on reviews from: QView Medical, Inc., BioSpace, PR Newswire, accessdata.fda.gov, RSNA Press Room

Last updated: 2026-07-19

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Press & Coverage

PR Newswire
QView Medical and Eve Wellness Announce Partnership to Advance Direct-to-Consumer Breast Cancer Screening With FDA-Approved AI
QView Medical partnered with Eve Wellness to offer direct-to-consumer breast cancer screening using QView's FDA-approved AI for breast ultrasound cancer detection. This collaboration aims to provide accessible and effective screening for women, particularly those with dense breast tissue, who may not benefit sufficiently from mammography alone.
2025-10
Qview Health
Qview Announces the release of Version 4.1.5 starting in December 2025
Qview Health announced the release of Version 4.1.5 of its Enterprise software, which includes a new feature for secure import, normalization, and cross-validation of tabular data from major clinical registries. This enhancement aims to improve quality measurement, reporting, and research in healthcare.
2025-12
AJR Online
Artificial Intelligence for Breast Ultrasound: AJR Expert Panel Narrative Review
This expert panel narrative review discusses AI tools for breast ultrasound, highlighting QVCAD as an FDA-approved application for use with Automated Breast Ultrasound (ABUS). It notes that QVCAD was approved via the more stringent premarket approval pathway, unlike other breast ultrasound AI applications.
2026-06
PR Newswire
QView Medical maintains leadership position in AI-powered breast cancer screening technology through alliance with GE Healthcare
QView Medical announced that its FDA-approved QVCAD software can now be launched directly on GE Healthcare's Inveniau2122 ABUS 2.0, streamlining workflow and potentially reducing reading time by up to 33% for breast cancer screening in women with dense breasts.
2021-11
Insight @ Dickinson Law
Health AI for Good Rather Than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices
This article discusses the need for a new regulatory framework for AI-based medical devices in the U.S., noting that the QVCAD System is one of the few devices that has received PMA approval, while most other AI/ML-based medical devices were 510(k)-cleared.
2021-09
PRLog
QView Medical Signs European Distribution Agreement to sell AI/QVCAD for Breast Cancer Detection
QView Medical signed a distribution agreement with Traf Intercontinental to sell its QVCAD System to breast imaging clinics in Europe. The QVCAD system received European approval (CE) in 2017 for use with 3D breast ultrasound systems.
2020-06
PMC
Should We Ignore, Follow, or Biopsy? Impact of Artificial Intelligence Decision Support on Breast Ultrasound Lesion Assessment
This study investigates the impact of AI decision support on breast ultrasound lesion assessment, referencing QVCAD's premarket approval for detecting mammography-occult lesions. It highlights the system's role in aiding radiologists during screening procedures.
2020-04
BioSpace
QView Medical Showcases FDA Approved QVCAD, First AI System for Concurrent Reading of ABUS Exams at RSNA
QView Medical showcased its FDA-approved QVCAD system at RSNA, emphasizing its ability to reduce interpretation time of screening ABUS exams while maintaining diagnostic accuracy. The system uses deep learning algorithms to detect suspicious areas in breast tissue.
2018-11

Videos

Product demos, reviews, and walkthroughs for QVCAD System.

View all on YouTube

Frequently Asked Questions

The QVCAD System integrates with 3D Automated Breast Ultrasound (ABUS) systems, such as GE Invenia ABUS 2.0, to aid radiologists in screening women with dense breast tissue. It concurrently displays AI-generated CAD marks and a C-thruu2122 Navigator image alongside original ABUS images, designed to reduce reading time and highlight suspicious areas.
The QVCAD System is FDA PMA-approved for concurrent reading with ABUS systems and has also received the CE Mark. This signifies that it has undergone rigorous testing and met established standards for medical device safety and effectiveness.
QVCAD is an aid, and its indicators are not for diagnostic characterization; physicians must concurrently review original ABUS images and not solely rely on CAD findings. There is an inherent risk of false positives or negatives, which could lead to additional workup or potentially missed lesions if over-reliance occurs.
QVCAD utilizes deep learning algorithms to detect suspicious areas in 3D ABUS images, significantly reducing interpretation time by up to 33% while maintaining diagnostic accuracy. This is particularly beneficial for dense breasts where mammography may miss cancers.
Alternatives include conventional, unaided reading of ABUS images or other CAD systems, though QVCAD is noted as the first FDA PMA-approved system for *concurrent* reading. QVCAD aims to improve efficiency and confidence compared to unaided reading of the large ABUS datasets.
Specific pricing information for the QVCAD System is not publicly available in the provided search results. Typically, such systems involve a capital expenditure for the software license and integration, which would require direct consultation with QView Medical or GE Healthcare.
QVCAD employs image pattern recognition processes and artificial neural networks, trained on a large database of over 20,000 ABUS cases, including 3,000 biopsy-proven cancer cases. The AI generates scores for suspicious areas to help distinguish potential lesions from normal tissue.

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