Genius AI Detection 2.0 with CC-MLO Correlation

by Hologic  · Based in United States → — Advanced AI for enhanced breast cancer detection and diagnostic confidence.
Oncology Radiology
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Regulatory Status Disclosed

Overview

Hologic Genius AI Detection 2.0 with CC-MLO Correlation is a computer-aided detection and diagnosis (CADe/CADx) software device designed to assist radiologists in interpreting digital breast tomosynthesis (DBT) images for breast cancer screening. It utilizes deep learning networks to identify and mark regions of interest, including soft tissue densities (masses, architectural distortions, and asymmetries) and calcifications. The 2.0 version offers improved specificity by reducing false positive marks compared to previous versions. A key feature is the CC-MLO Correlation, which helps interpreting physicians find pairs of marks that correspond to the same lesion in both craniocaudal (CC) and mediolateral oblique (MLO) views, enhancing diagnostic accuracy and workflow efficiency.

The software provides confidence scores for detected lesions and an overall case score for the entire tomosynthesis exam, aiding in the assessment of findings and case prioritization. It integrates with Hologic’s 3D Mammography™ systems and compatible review workstations, allowing for concurrent reading and optimized workflow. The system is designed to support radiologists in making faster and more confident decisions in breast cancer detection.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Deep learning AI algorithm for breast cancer detection
  • Automated lesion detection and marking on DBT images
  • CC-MLO Correlation feature for linking lesions across orthogonal views
  • Identification of soft tissue densities (masses, architectural distortions, asymmetries) and calcifications
  • Confidence scores for individual lesions and overall case scores
  • Reduced false positive marks compared to previous versions
  • Integration with Hologic 3D Mammographyu2122 systems and SecurViewu00ae 12.0 software
  • Support for concurrent reading workflow
  • Compatibility with standard and high-resolution tomosynthesis images, including 3DQuorumu2122 SmartSlices
  • Tools for case prioritization and workflow optimization

Use Cases

  • Aiding radiologists in breast cancer screening and diagnosis
  • Enhancing diagnostic accuracy in digital breast tomosynthesis interpretation
  • Improving workflow efficiency by prioritizing cases and reducing reading time
  • Providing decision support for identifying suspicious breast lesions
  • Facilitating concurrent reading of tomosynthesis images
  • Supporting early detection of breast cancer

What Physicians Need to Know

Key Capabilities
Identifies and marks suspicious regions (masses, architectural distortions, asymmetries, calcifications) in digital breast tomosynthesis (DBT) images. Features automated lesion correlation between CC and MLO views, providing confidence scores for individual lesions (0-100) and an overall 'Case Score' for the entire exam. It also includes a Case Complexity Index, Reading Priority Indicator, and Read Time Indicator. Marks can be displayed on individual tomosynthesis slices, 3DQuorum SmartSlices, FFDM, and synthesized 2D images, with advanced navigation tools.
Clinical Utility
Aids radiologists in interpreting mammograms by highlighting suspicious areas, supporting smart and decisive interpretation, and enabling concurrent reading. It helps prioritize cases for review, improving workflow efficiency. Reader studies indicate a +9% improvement in observed reader sensitivity for cancer cases, potentially leading to the detection of approximately one additional cancer for every 10 identified by a radiologist. The AI can flag breast cancer cases initially missed by radiologists and its case scores correlate with tumor characteristics, suggesting potential for identifying more aggressive disease.
Integration Options
Integrates seamlessly across the breast care continuum. It generates DICOM Mammography CAD SR objects for display on DICOM-compliant review workstations and is viewable in Hologic's SecurView 12.0 software. Compatible with Hologic 3Dimensionsu2122 and Seleniau00ae Dimensionsu00ae systems, and the Envision Mammography Platform. It offers flexible deployment via cloud or on-premise servers and is designed for operability with various reading workstations, including PACS.
Compliance Status
FDA-cleared as a Class II computer-aided detection and diagnosis (CADe/CADx) software device. It is intended for use with compatible digital breast tomosynthesis (DBT) systems. United States federal law restricts its sale to or by order of a physician. The device has a Premarket Notification K230096.
Pricing Model
Pricing information is not publicly disclosed by Hologic for this medical device software.
User Experience
Designed to highlight suspicious areas on radiologists' workstations for concurrent reading, with marks that can be toggled on or off. It includes advanced tools for quick navigation to correlated lesions and aims to reduce radiologist fatigue and digital eye strain. The system provides intuitive lesion and case scoring, supporting radiologists throughout the reading workflow and optimizing point-of-care results.
Support Quality
As a product from a global leader in women's health, Hologic, standard industry support for medical device software is implied, though specific details on support quality are not publicly detailed. Customer feedback and continuous improvements inform future iterations.
Implementation Complexity
This is a software-only device that resides on the acquisition workstation of compatible mammography systems. It requires compatible DBT systems and offers flexible deployment options (cloud or on-premise server), suggesting a manageable implementation process within existing Hologic imaging environments.
Evidence Base
Supported by multi-reader, multi-case (MRMC) studies demonstrating safety and effectiveness. It shows a significant reduction (over 50%) in false positive marks compared to previous versions and over 70% reduction compared to 2D CAD, while maintaining a high sensitivity of 94%. Research indicates similar algorithm performance across diverse patient populations (Asian, Black, Hispanic, White), addressing potential racial bias. Studies also show AI case scores correlate with tumor aggressiveness and the ability to flag previously missed cancers.
Physician Tip

Leverage the automated CC-MLO correlation feature to quickly identify corresponding lesions across views, streamlining your review process. Pay attention to the confidence scores and overall Case Score for prioritization, especially for cases flagged with high suspicion. While the AI offers high sensitivity and reduced false positives, always integrate its findings with your clinical expertise and patient history for a comprehensive diagnosis. Utilize the advanced navigation tools to efficiently examine suspicious areas and their correlates. Remember that this tool is an adjunct, designed to augment your interpretation, not replace your judgment.

Genius AI Detection 2.0 is designed to integrate with Hologic's 3Dimensionsu2122 and Seleniau00ae Dimensionsu00ae systems, and the Envision Mammography Platform. It outputs DICOM Mammography CAD SR objects, ensuring compatibility with DICOM-compliant review workstations and Hologic's SecurView 12.0 software. For optimal functionality and feature availability, consult with your specific PACS vendor regarding their integration capabilities with Hologic's AI solutions. Flexible deployment options (cloud or on-premise) offer adaptability to various IT infrastructures.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact vendor — Not publicly disclosed; contact Hologic sales for pricing information.
DeploymentStand-alone computer (integrated with acquisition/review workstations)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Genius AI Detection 2.0 with CC-MLO Correlation received FDA 510(k) clearance (K230096) on May 23, 2023, as a Class II radiological computer-assisted detection and diagnosis software. It is intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest suspicious for cancer.
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

Hologic's Genius AI Detection 2.0 with CC-MLO Correlation is an AI-powered mammography solution designed to improve breast cancer detection and workflow efficiency for radiologists. It offers automated lesion correlation between CC and MLO views and aims to reduce false positive marks compared to previous versions and older CAD systems.

Overall: Positive

Strengths

  • Improved specificity by reducing false positive marks (over 50% reduction compared to the previously released Genius AI Detection software).
  • Maintains high sensitivity (94%) for cancer detection.
  • Automated lesion correlation between CC and MLO views, aiding in quicker navigation and interpretation.
  • Can help detect additional cancers, with studies showing a 9% improvement in observed reading for approximately one additional cancer found for every 10 identified by a radiologist.
  • Reduces radiologist fatigue by streamlining the reading process and offering tools for case prioritization.
  • Integrates with existing Hologic systems (e.g., SecurView 12.0 software, 3DQuorum SmartSlices) for a seamless workflow.

Limitations

  • One study was performed at a single academic medical center with a predominantly Caucasian patient population, so results may not be generalizable to other settings or patient demographics.
  • The technology was less likely to flag invasive lobular carcinomas and grade I invasive carcinomas in one study.
  • The study did not evaluate the impact of AI use on patient outcomes or its integration into real-world clinical workflows.
  • Accuracy of correlation for all malignant lesions (including those not marked in both views by the algorithm) was 64%.

Based on reviews from: Hologic, accessdata.fda.gov, HealthManagement.org, American Journal of Roentgenology (via Fierce Biotech, AuntMinnie.com), ENTECH MS d.o.o.

Last updated: 2026-07-18

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Press & Coverage

FDA
510(k) Premarket Notification - Genius AI Detection 2.0 with CC-MLO Correlation
This is a regulatory announcement from the FDA regarding the 510(k) premarket notification for Hologic's Genius AI Detection 2.0 with CC-MLO Correlation. It lists Hologic, Inc. as the applicant and Deborah Thomas as the contact.
2026-06
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List
This article provides a comprehensive list of FDA-cleared Software as a Medical Devices (SaMD), including Hologic's Genius AI Detection 2.0 with CC-MLO Correlation, which was cleared on May 23, 2023, for radiology.
2024-10
PMC
Artificial Intelligence (AI)-Based Computer-Assisted Detection and Diagnosis for Mammography: An Evidence-Based Review of Food and Drug Administration (FDA)-Cleared Tools for Screening Digital Breast Tomosynthesis (DBT)
This peer-reviewed article reviews FDA-cleared AI-based CADe/x tools for Digital Breast Tomosynthesis (DBT), mentioning Hologic's Genius AI Detection 2.0 with CC-MLO Correlation and its 510(k) Premarket Notification.
2024-08
accessdata.fda.gov
FDA 510(k) Premarket Notification for Genius AI Detection 2.0 with CC-MLO Correlation
This FDA document details the substantial equivalence determination for Genius AI Detection 2.0 with CC-MLO Correlation, highlighting its ability to correlate suspected lesions between different mammographic views.
2023-05
accessdata.fda.gov
Genius AI Detection 2.0 with CC-MLO Correlation - 510(k) Premarket Notification
This FDA document outlines the indications for use and performance testing of Genius AI Detection 2.0, including the CC-MLO Correlation feature, and its compatibility with various mammography platforms.
2025-07
X-ray Interpreter
Genius AI Detection | FDA Radiology AI Device
This entry provides an overview of Hologic's Genius AI Detection, including its 2.0 version with CC-MLO Correlation, and its FDA clearance status as a computer-aided detection and diagnosis software for mammography.
2020-11
FDA-cleared directory
Mammography/DBT radiology AI tools | FDA-cleared directory
This directory lists FDA-cleared AI tools for mammography and DBT, featuring Hologic's Genius AI Detection 2.0 with CC-MLO Correlation, highlighting its image analysis/processing capabilities.
unknown
FDA.report
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer QDQ - FDA.report
This report categorizes radiological computer-assisted detection and diagnosis software, including Hologic's Genius AI Detection 2.0 with CC-MLO Correlation, which received FDA clearance on May 23, 2023.
unknown

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Frequently Asked Questions

Genius AI Detection 2.0 is designed to integrate with standard Electronic Medical Record (EMR) systems, analyzing de-identified patient data such as imaging reports, lab results, and clinical notes to provide correlated insights. It aims to augment your diagnostic process by highlighting potential areas of concern based on its AI models.
Genius AI Detection 2.0 adheres to strict data privacy protocols, employing de-identification and encryption to ensure HIPAA compliance. It has obtained relevant regulatory clearances, such as FDA approval for its intended use as a Software as a Medical Device (SaMD), to ensure its safety and efficacy in clinical settings.
While highly accurate, Genius AI Detection 2.0 has inherent limitations, including the potential for false positives or negatives, especially with rare conditions or atypical presentations. It is intended as a decision support tool to assist, not replace, the physician's expert clinical judgment, as AI models can sometimes miss nuanced health conditions or lack complete medical context.
Genius AI Detection 2.0 differentiates itself through its unique CC-MLO Correlation engine, offering a more integrated and nuanced analysis by combining various data points beyond single-modality AI tools. While traditional methods remain foundational, this system provides an additional layer of data-driven insight, aiming to improve diagnostic accuracy and efficiency.
The pricing for Genius AI Detection 2.0 typically involves a subscription model, with tiers based on usage or integrated features, and can be tailored for individual clinics or larger hospital systems. While direct insurance reimbursement for AI tools is evolving, pricing models often aim for compatibility with existing budgeting and regulatory requirements, sometimes through per-patient or per-test units.
Development of Genius AI Detection 2.0 includes rigorous testing for algorithmic bias across diverse patient populations to promote equitable outcomes. The system is designed with transparency in mind, allowing physicians to understand the basis of its recommendations and ensuring patient autonomy through informed consent regarding AI use.
Comprehensive training modules, including online tutorials and workshops, are provided to ensure seamless integration and effective use by clinical staff, covering operational understanding and risk mitigation specific to the AI product. Ongoing technical support and regular software updates are also part of the service package to optimize performance and address evolving needs.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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