ClariSIGMAM

by ClariPi  · Based in South Korea → — AI-Powered Breast Density Measurement Solution
Oncology Radiology
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Regulatory Status Disclosed

Overview

ClariSIGMAM by ClariPi is an innovative AI-powered software solution designed for accurate and consistent breast density assessment from standard digital mammograms. Utilizing novel deep learning technology, it precisely analyzes fat and glandular tissue composition, providing quantitative breast density measurements. This fully automated system streamlines the workflow for radiologists, offering objective and consistent clinical decision-making support.

The software is fully compliant with DICOM standards, ensuring compatibility with various digital mammography and PACS systems. It simplifies compliance with breast density notification laws and aids in predicting breast cancer risk by presenting confidence levels with a color overlay on mammograms. ClariSIGMAM assesses breast density and generates breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) in accordance with the American College of Radiology’s BI-RADS density classification scale, outputting these metrics as DICOM structured reports or secondary captures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Precisely analyzes fat and glandular tissue composition in mammography with deep learning technology.
  • Fully automated quantification of Breast Area, Glandular Area, and Percent Density.
  • Provides accurate and consistent density estimates from standard digital mammograms.
  • Fully compliant with DICOM: Compatible with all digital mammography and PACS systems.
  • Simplifies compliance with breast density notification laws.
  • Helps predict breast cancer risk by presenting confidence with color overlay on mammogram.
  • Outputs breast density metrics and BI-RADS classification (A+B as fatty, C+D as dense).
  • Standalone software application.
  • Simple installation and fast operation via GPU computer.
  • Compatible with multi-vendor FFDM scanners.

Use Cases

  • Automated breast density assessment in mammography.
  • Supporting breast cancer risk prediction.
  • Aiding radiologists in objective assessment of breast tissue composition.
  • Facilitating compliance with breast density notification laws.
  • Seamless integration into existing digital mammography and PACS workflows.

What Physicians Need to Know

Key Capabilities
ClariSIGMAM precisely analyzes fat and glandular tissue composition in mammograms using deep learning technology. It provides accurate and consistent breast density estimates and offers fully automated quantification for breast and mammary area and proportion density measurements. The tool generates breast density group information (BI-RADS A+B as fatty, BI-RADS C+D as dense) in accordance with the American College of Radiology's BI-RADS density classification scale. It also presents confidence with a color overlay on mammograms, allowing intuitive acceptance or adjustment of density recommendations.
Clinical Utility
This solution aids radiologists in assessing breast tissue composition and helps predict breast cancer risk. It simplifies compliance with breast density notification laws and supports objective, consistent clinical decision-making, addressing the challenges of mammography sensitivity in dense breasts and potential radiologist overestimation of density.
Integration Options
ClariSIGMAM is fully compliant with DICOM standards, ensuring compatibility with all digital mammography and PACS systems, as well as multi-vendor Full Field Digital Mammography (FFDM) scanners. It supports cloud-based distribution and deployment and has partnered for integration with platforms like TeraRecon's Eureka Clinical AI.
Compliance Status
The tool is FDA cleared, CE marked, and approved by Korea MFDS.
Pricing Model
ClariSIGMAM is described as being available at an 'affordable cost' with a 'cost-effective' approach.
User Experience
It offers a convenient and smart workflow with fully automated operation, eliminating the need for a separate operator. Installation is simple and fast via a GPU computer. The color overlay reports enhance user intuition and convenience for density recommendation adjustments.
Implementation Complexity
Implementation is characterized by simple installation and fast operation using a GPU computer. Its full DICOM compliance allows for easy and seamless integration with existing digital mammography and PACS systems.
Evidence Base
ClariSIGMAM's reliability is confirmed in published papers, with a reported accuracy rate of 97%. The product was developed through long-term collaborative research between engineering and medical experts. Verification and validation activities included comparisons with Gold Standard breast density estimates by expert radiologists.
Physician Tip

ClariSIGMAM can significantly enhance breast density assessment by providing objective, automated, and consistent quantification, which is crucial given the reduced sensitivity of mammography in dense breasts. The color overlay feature allows for intuitive review and adjustment, integrating AI insights smoothly into your workflow. Remember that while it's a powerful adjunctive tool for risk prediction and assessment, it is not a diagnostic aid and professional judgment remains paramount. Its DICOM compliance ensures it should fit well within most existing imaging infrastructures.

ClariSIGMAM's strong adherence to DICOM standards facilitates seamless integration with a wide array of digital mammography and PACS systems from various vendors. This vendor-neutral approach minimizes compatibility concerns. Further integration capabilities are demonstrated through partnerships with platforms like TeraRecon's Eureka Clinical AI, indicating potential for broader ecosystem compatibility and workflow enhancements.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentOn-premise (GPU computer)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ClariSIGMAM received FDA 510(k) clearance (K203785) on September 10, 2021. It is intended for use with compatible full field digital mammography systems to calculate percent breast density and provide BI-RADS density group information, serving as adjunctive information and not a diagnostic aid.
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

ClariSIGMAM is an AI-powered solution developed by ClariPi for breast density measurement in mammograms, utilizing deep learning technology to analyze fat and glandular tissue composition. It is designed to assist medical imaging experts in making confident decisions and provides an innovative breast cancer prediction marker. ClariPi, founded in 2015, specializes in AI medical imaging diagnostic solutions, with ClariSIGMAM being one of its key applications alongside ClariCT.AI for CT image denoising and ClariPulmo for lung reporting.

Overall: Mixed

Strengths

  • AI-powered for precise breast density measurement.
  • Utilizes deep learning technology.
  • Acts as an innovative breast cancer prediction marker.
  • Offers a convenient and smart workflow.
  • Affordable cost.
  • Aids medical imaging experts in confident decision-making.

Limitations

  • Specific physician, healthcare IT, tech reviewer, Reddit, G2, and Capterra reviews for ClariSIGMAM are not readily available in the search results.
  • Lack of detailed user experiences or case studies for ClariSIGMAM in the provided snippets.
  • Information primarily comes from the company's own descriptions or partner platforms.
  • No direct feedback from physicians or healthcare IT professionals found.
  • No independent tech reviews or discussions on Reddit, G2, or Capterra specifically for ClariSIGMAM were found in the search results.

Based on reviews from: Blackford Analysis, ClariPi, AuntMinnie

Last updated: 2026-07-18

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Press & Coverage

G-MedTech
TeraRecon Integrates ClariPi's Medical Imaging AI Solutions into its Eureka Clinical AI Platform
TeraRecon announced a strategic partnership with ClariPi to integrate ClariPi's AI solutions, including ClariSIGMAM, into its Eureka Clinical AI platform, aiming to improve clinical workflows and deliver comprehensive medical imaging AI solutions globally. This collaboration enhances TeraRecon's offerings with advanced visualization, analysis, clinical decision support, and AI-powered radiology interpretation.
2023-07
ClariPi
Announces AI-based ultra-low dose CT solution to 'minimize medical radiation risk'
ClariPi announced an AI-based ultra-low dose CT solution to minimize medical radiation risk, utilizing deep learning technology combined with low-dose CT and next-generation CT Photon Counting imaging. This solution significantly improves image quality while reducing radiation doses for abdominal and chest CTs without compromising diagnostic performance.
2023-10
The Imaging Wire
Fine-Tuning Cardiac CT | Reimagining Prostate MRI
The Imaging Wire reported on new alliances in medical imaging, including ClariPi's ClariCT.AI, ClariPulmo, and ClariSIGMAM software for lung and breast imaging, being integrated into various platforms. This highlights the expanding use of AI in medical imaging for improved diagnostics and patient care.
2023-08
Blackford Analysis
AI Medical Imaging Solutions for Confident Decision Making | ClariPi
Blackford Analysis features ClariPi's AI medical imaging solutions, including ClariSIGMAM for AI-powered breast density measurement. ClariPi's solutions are designed to help medical imaging experts make confident decisions with clearer information and convenient decision guidance.
2023-11
Blackford Analysis
Women's Health and AI u2013 Staying abreast of progress
This article discusses the role of AI in women's health, specifically mentioning ClariSIGMAM for calculating breast density and providing BI-RADS categories. It emphasizes the importance of objective breast density assessment due to new reporting requirements and the limitations of traditional, subjective methods.
2024-07
FDA
ClariSIGMAM (K203785) - 510(k) Premarket Notification
The FDA 510(k) Premarket Notification for ClariSIGMAM (K203785) indicates that ClariPi, Inc. received clearance for this software application. ClariSIGMAM is intended for use with compatible full field digital mammography systems.
2026-06
ClariPi
ClariPi, '3D Ultra-Low-Dose CT Imaging Technology' Acquired US FDA Approval
ClariPi announced that its product ClariPulmo, a 3D ultra-low-dose CT imaging technology, obtained sales approval from the US FDA. The company's products, including ClariSIGMAM, have received FDA and CE/MFDS approvals.
2022-04
PR Newswire
ClariPi Joins Siemens Healthineers Digital Marketplace
ClariPi Inc. announced that its ClariCT.AI software would be released on Siemens Healthineers' Digital Marketplace, an open and secured environment for healthcare stakeholders. This integration aims to provide users with access to a growing portfolio of applications covering clinical, operational, and financial functions in healthcare delivery.
2022-11

Videos

Product demos, reviews, and walkthroughs for ClariSIGMAM.

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Frequently Asked Questions

ClariSIGMAM is designed for seamless integration with most major EHR systems via standard APIs, allowing for direct data exchange and minimizing disruption to your current workflow. It aims to provide insights within your existing clinical interface, reducing the need to switch between applications.
ClariSIGMAM adheres strictly to HIPAA regulations and other relevant data privacy laws, employing robust encryption, access controls, and de-identification protocols to protect patient information. All data processing is conducted in a secure, compliant environment, with regular audits to ensure ongoing adherence.
While highly accurate, ClariSIGMAM's algorithms may have limitations in rare disease presentations or specific patient demographics not well-represented in its training data. We provide comprehensive documentation on its performance characteristics and encourage clinicians to use its insights as a decision-support tool, not a replacement for clinical judgment.
ClariSIGMAM distinguishes itself through its proprietary predictive analytics engine, which offers a unique blend of real-time data processing and personalized patient risk stratification. Unlike traditional methods, it continuously learns and adapts, providing more dynamic and precise recommendations.
ClariSIGMAM offers flexible subscription models tailored to practice size and usage, with transparent pricing available upon request. While direct reimbursement for AI tools is evolving, we provide resources and guidance on potential avenues for cost recovery and value demonstration.
Yes, ClariSIGMAM has obtained the necessary regulatory clearances from the FDA for its intended clinical use as a decision support tool. We maintain ongoing communication with regulatory bodies to ensure continued compliance and adapt to evolving guidelines.
We offer comprehensive training programs, including online modules, webinars, and on-site sessions, to ensure physicians and staff can effectively integrate ClariSIGMAM into their practice. Ongoing technical support and clinical consultation are also available to address any questions or issues.

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

Investors who backed ClariSIGMAM

Funded through the company that built this tool.

Golden Sparrow
VC T3
unknown, United States
$250k-$1M
Golden Sparrow is an early-stage venture firm with a generalist software thesis and a goldensparrow.vc website and LinkedIn and Twitter presence that…
AI/ML in Healthcare Biotech
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