CogNet QmTRIAGE

by MedCognetics  · Based in United States → — Precision AI Transforming Healthcare
Oncology Radiology
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Not disclosed
Regulatory Status Disclosed

Overview

MedCognetics’ CogNet QmTRIAGE is an advanced artificial intelligence (AI) software platform designed to integrate into radiology workflows for breast cancer screening and triage. It utilizes machine learning algorithms to analyze 2D FFDM (Full-Field Digital Mammography) and DBT (Digital Breast Tomosynthesis) exams, flagging suspicious findings to help radiologists prioritize their worklist.

The platform aims to improve early breast cancer detection, particularly across diverse patient populations, by employing unbiased algorithms trained on global datasets. CogNet QmTRIAGE functions as a passive notification and prioritization-only tool, enhancing clinical efficiency and reducing radiologist burnout by streamlining the review process.

Beyond cancer screening, the technology can also analyze tissue for the presence of breast arterial calcifications, an indicator related to cardiovascular health. It supports flexible deployment options, including on-premise, cloud-based, or via the web.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven triage for mammography images (FFDM and DBT)
  • Flags suspicious cases for prioritized review
  • Integrates into existing radiology workflows (PACS/workstations)
  • Utilizes advanced AI and machine learning algorithms
  • Designed to detect early signs of cancer across all ethnicities with unbiased algorithms
  • Reduces radiologist review time and burnout
  • Can be deployed on-premise, in the cloud, or via the web
  • Analyzes breast arterial calcifications (beyond cancer screening)

Use Cases

  • Prioritizing mammography exams with suspicious findings
  • Improving early breast cancer detection
  • Reducing radiologist workload and burnout
  • Enhancing clinical efficiency in radiology departments
  • Addressing disparities in cancer detection across diverse patient groups
  • Facilitating faster patient care by enabling same-day additional imaging or biopsies

What Physicians Need to Know

Key Capabilities
AI-enabled software for breast cancer screening, specifically for triage and prioritization of mammograms. It analyzes 2D FFDM and 3D DBT mammography exams, flagging suspicious findings for prioritized review. The system is designed to detect early manifestations of cancer across diverse patient populations by mitigating data bias through training on a global dataset.
Clinical Utility
Aids radiologists in managing high caseloads and reducing burnout by optimizing workflow through worklist prioritization. It aims to reduce the time radiologists need to review cases and has demonstrated a reduction in time to additional imaging and time to biopsy diagnosis. The platform enhances the efficiency and effectiveness of medical imaging and supports earlier identification of potentially suspicious findings.
Integration Options
Integrates into existing radiology workflows and IT systems, including PACS/Workstations for flagging suspicious studies. The software can be deployed on customer premises, via the cloud, or through the web. MedCognetics also offers an embedded AI system that integrates directly into mammography devices for real-time image processing.
Compliance Status
U.S. FDA 510(k) cleared as a Class II medical device (Product Code QFM, Radiological computer aided triage and notification software). The initial QmTRIAGE (K220080) was cleared for 2D FFDM, and the enhanced CogNet AI-MT+ (K252482) has received clearance for 3D DBT mammography. The software was developed under an ISO 13485-certified quality management system.
Pricing Model
Described as a cloud-based AI software as a service (SaaS). Specific pricing details are not publicly disclosed and typically require direct inquiry with the vendor.
User Experience
Operates as a passive notification, parallel-workflow tool that prioritizes studies without removing images from the radiologist's worklist or providing diagnostic information beyond triage. It is designed to be accessible and reduce review time.
Implementation Complexity
Designed for integration into existing imaging and IT systems, supporting flexible deployment options including on-premises, cloud, or web-based. Inputs are standard DICOM format mammogram studies. The embedded AI option can simplify deployment by eliminating external workstations.
Evidence Base
Trained on a diverse global patient dataset to ensure consistent performance across various ethnicities and mitigate data bias. Initial FDA clearance for QmTRIAGE was supported by a validation study demonstrating 87% sensitivity and 89% specificity in identifying breast cancer signs, with an AUROC of 0.9569. The company has also received NIH support for inclusive AI research.
Physician Tip

CogNet QmTRIAGE (and its newer iterations, CogNet AI-MT/AI-MT+) serves as a valuable AI-powered triage tool, not a diagnostic replacement. Leverage its worklist prioritization feature to manage high volumes of mammograms, focusing your attention on potentially suspicious cases first. Remember that the AI's role is to flag studies for your expert review, not to make a definitive diagnosis. Its training on diverse datasets aims to reduce bias, which is crucial for equitable care across patient populations. Integrate it thoughtfully into your existing workflow to maximize efficiency and potentially reduce diagnostic delays. Always maintain your standard of care for full patient evaluation.

The system is designed for seamless integration into standard radiology workflows, connecting with PACS/Workstations via DICOM for image transfer and result notification. Its flexible deployment options (on-premises, cloud, web, or embedded directly into mammography devices) allow for adaptation to various IT infrastructures. This flexibility aims to minimize disruption and enhance real-time processing capabilities.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Not disclosed — Not disclosed
DeploymentCloud-based, on-premise, or via the web
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

CogNet QmTRIAGE received FDA 510(k) clearance (K220080) on September 29, 2022, for passive notification and prioritization of 2D FFDM screening mammograms. Its enhanced version, CogNet AI-MT+, also received 510(k) clearance for analyzing digital breast tomosynthesis (DBT) exams.
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

CogNet QmTRIAGE, also referred to as CogNet AI-MT and CogNet AI-MT+, is an AI-powered software designed to assist radiologists in prioritizing mammogram screenings for breast cancer detection. It integrates into existing radiology workflows to flag suspicious findings, aiming to reduce review time and address radiologist caseloads. The software has received FDA 510(k) clearance and is noted for being trained on diverse patient datasets to mitigate data bias.

Overall: Positive

Strengths

  • Prioritizes suspicious mammograms, potentially reducing radiologist review time and improving workflow efficiency.
  • Aims to detect early manifestations of cancer, including small or obscured tumors in dense breast tissue.
  • Trained on globally diverse patient datasets to reduce data bias and improve outcomes across various ethnicities.
  • Integrates into existing radiology workflow without requiring additional tasks from the radiologist.
  • Provides a second validation point, which may increase radiologists' confidence.
  • Cloud-based software, eliminating the need for installation.

Limitations

  • No direct physician or healthcare IT reviews are publicly available outside of regulatory documents and company statements.
  • No reviews found on Reddit, G2, or Capterra specifically for CogNet QmTRIAGE.
  • The software is a passive notification tool and does not replace complete evaluation by a qualified physician.
  • Does not provide diagnostic information beyond triage and prioritization.
  • Does not remove images from the interpreting physician's worklist.
  • Some advanced configurations may require additional clarification, though support is reportedly responsive for other software on Capterra.

Based on reviews from: MedCognetics, Inc. FDA 510(k) Premarket Notification, MedCognetics' AI Enabled Breast Cancer Screening Software Receives FDA Clearance, Medcognetics, Inc. FDA 510(k) Premarket Notification (Renamed to CogNet AI-MT), Dallas' MedCognetics Gets FDA Clearance for Its AI-Enabled Breast Cancer Screening Software, FDA says yes to MedCognetics breast cancer screening AI - pharmaphorum, Unbiased AI for Mammography u2013 CogNet AI-MT - Blackford Analysis, FDA Clears AI-Powered Triage Platform for Digital Breast Tomosynthesis

Last updated: 2026-07-19

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Press & Coverage

Constat
CogNet QmTRIAGE (K220080) u2014 FDA 510(k) evidence - Constat
This article details the FDA 510(k) clearance for CogNet QmTRIAGE by MedCognetics, Inc. on September 29, 2022, highlighting its product code QFM and radiology application. It includes parsed clearance evidence such as validation studies and cited predicates.
2022-09
FDA
510(k) Premarket Notification - FDA
This is the official FDA 510(k) Premarket Notification for CogNet QmTRIAGE, submitted by Medcognetics, Inc. It provides regulatory information, including the applicant, contact details, regulation number (892.2080), and classification product code (QFM).
2026-07
Euskadi.eus
Inteligencia artificial en el programa de cribado de cu00e1ncer de mama - Euskadi.eus
This report discusses artificial intelligence in breast cancer screening programs, mentioning CogNet QmTRIAGE as a tool that analyzes 2D FFDM screening mammograms to flag suspicious findings for prioritization. It notes that the tool does not replace a complete evaluation.
2022-10
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List - Orthogonal
This comprehensive list of FDA-cleared Software as a Medical Devices (SaMD) includes CogNet QmTRIAGE, cleared on September 29, 2022, for radiology applications. The list is compiled from publicly available FDA data and other regulatory search tools.
2024-10
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
This article discusses Command Line as a Medical Device (CLaMD) and references MedCognetics' CogNet QmTRIAGE as a 'passive notification-only, parallel-workflow software tool' that sends results to a PACS/Workstation. It highlights how such devices integrate into existing clinical workflows without a dedicated user interface.
2025-05
FDA
December 11, 2025 Medcognetics, Inc. John Jenkins Chief Quality Officer 17217 Waterview Parkway Suite 1.202E Dallas, Texas 75252 - accessdata.fda.gov
This FDA document details the 510(k) submission for CogNet AI-MT+ (formerly CogNet QmTRIAGE), a non-invasive computer-assisted triage and notification software for DBT screening mammograms. It outlines the device's description, intended use, and its role in prioritizing suspicious findings.
2025-12
Journal of Korean Society of Radiology
Application of Artificial Intelligence in Breast Imaging: Current Landscape and Prospects
This peer-reviewed article on the application of AI in breast imaging lists CogNet QmTRIAGE by MedCognetics, Inc. as a tool for breast lesion characterization in mammography.
2023-12
FDA.report
May 23, 2024 VinBigData Joint Stock Company Nguyet (Jun) Phan Regulatory Affairs Specialist Symphony Office Building, Chu H - FDA.report
This FDA document references CogNet QmTRIAGE (K220080) as a predicate device for VinDr-Mammo, another radiological computer-assisted prioritization software. It describes QmTRIAGE as a passive notification tool for prioritizing patients with suspicious findings in 2D FFDM screening mammograms.
2024-05

Videos

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Frequently Asked Questions

CogNet QmTRIAGE, also known as CogNet AI-MT/AI-MT+, integrates directly into existing radiology workflows and PACS/workstations. Its primary function is to analyze mammogram images (2D FFDM and 3D DBT) to detect suspicious findings and prioritize cases, enabling radiologists to review urgent studies first and manage increasing imaging volumes more efficiently.
Yes, CogNet QmTRIAGE has received FDA 510(k) clearance as a Class II medical device for radiological computer-aided triage and notification software. It is HIPAA compliant and ensures patient data privacy by promoting anonymization of data prior to analysis.
CogNet QmTRIAGE is a passive notification tool intended solely for prioritization and triage, not for providing diagnostic information or replacing a full patient evaluation by an MQSA qualified interpreting physician. It is limited to categorizing exams and does not remove images from the radiologist's worklist.
MedCognetics emphasizes that CogNet QmTRIAGE's AI algorithm is trained on a diverse global dataset to mitigate data bias. This approach aims to ensure consistent performance across various ethnicities and patient populations, promoting health equity in cancer detection.
By flagging suspicious mammography exams for prioritized review, CogNet QmTRIAGE helps radiologists manage high imaging volumes and focus on critical cases more quickly. This can lead to earlier identification of potentially suspicious findings, potentially reducing delayed diagnoses and patient anxiety by enabling faster follow-up.
CogNet QmTRIAGE offers flexible deployment options, including on-premise, cloud-based, or via the web. Notably, the technology can also be embedded directly into mammography systems, which helps eliminate latency and deliver immediate image analysis.
Specific pricing or licensing models for CogNet QmTRIAGE are not publicly detailed in the available information. Healthcare facilities interested in implementation would typically need to contact MedCognetics directly for a customized quote based on their specific needs and integration requirements.

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