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PowerLook Density Assessment

by iCAD · Based in United States → — The world's first multi-vendor deep learning algorithm for standardizing breast density assessments.

Obstetrics & Gynecology Oncology Radiology

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Regulatory Status Disclosed

Overview

PowerLook® Density Assessment, formerly branded as iReveal, is an automated breast density software solution developed by iCAD. It is designed to analyze “for processing” digital mammograms and calculate the dense tissue area of each breast. The software uses deep-learning AI to provide a Calibrated Density Category, mapping the percentage of breast density and dispersion to a BI-RADS® 5th Edition breast density category (a-d).

This innovative solution aims to remove the challenges of subjectivity traditionally associated with visual breast density assessment by radiologists, which can vary significantly. By delivering objective, reliable, and consistent breast density assessments, PowerLook Density Assessment empowers clinicians to further personalize breast cancer screening recommendations for patients.

The software is a stand-alone application designed to interoperate with various digital radiography (DR) and computed radiography (CR) mammography systems, including compatibility with Digital Breast Tomosynthesis (DBT) and synthetic 2D images. Results are displayed in the form of a DICOM mammography structured report or secondary capture on a mammography workstation, high-resolution monitor, or in a printed case report.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

Automated breast density assessment
Analyzes digital mammograms for processing
Calculates dense tissue area and total breast area
Provides BI-RADSu00ae 5th Edition density category (a-d)
Removes subjectivity in breast density reporting
Deep-learning AI multi-vendor solution
Integrates and automates breast density reporting within RIS/MIS
Compatible with Digital Breast Tomosynthesis (DBT) and synthetic 2D images
Analyzes dispersion and texture of breast tissue
Designed to process approximately 60-120 cases per hour

Use Cases

Standardizing breast density assessments
Personalizing breast cancer screening recommendations
Identifying patients who may need supplemental screening or are at higher risk
Assisting in communication of breast density with referring physicians
Automating breast density reporting
Reducing unnecessary additional imaging and costs

What Physicians Need to Know

Evidence Base

PowerLook Density Assessment aligns with the BI-RADSu00ae 5th edition density categories, analyzing the dispersion and texture of breast tissue. It addresses the known subjectivity and variability in radiologists' visual breast density assessments.

Clinical Validation Studies

The software has undergone clinical standalone performance studies demonstrating accurate estimation of percent breast density (PBD), dense tissue area, total breast area, and BI-RADS breast density category. Its BI-RADS categorization was calibrated to mimic the consensus of 13 expert radiologists. A clinical study showed statistical agreement with a panel of 10 expert radiologists, and its mean absolute error for PBD was less than that of 9 out of 10 radiologists. It received FDA clearance.

Alert Fatigue Management

By providing objective and consistent breast density assessments, the tool helps standardize reporting and reduce inter- and intra-reader variability, which can indirectly mitigate issues related to subjective interpretation and potential 'alert fatigue' from inconsistent manual assessments.

Differential Diagnosis Support

The tool provides a BI-RADS density category, which is a critical risk factor for breast cancer and guides clinicians in identifying patients who may benefit from supplemental screening. It aids in personalizing breast cancer screening recommendations.

Guideline Update Frequency

PowerLook Density Assessment aligns with the BI-RADS 5th Edition lexicon. iCAD regularly updates its software, with version 4.0 cleared by the FDA in July 2021, and an updated version launched in October 2021. It helps facilities adhere to updated FDA regulations requiring specific breast density information and patient notification in mammography reports, enforced from September 2024.

Clinical Workflow Integration

Results are designed for display on mammography workstations, high-resolution monitors, or in printed case reports. It offers seamless integration with multiple PACS, reading workstations, and Radiology Information Systems (RIS)/Management Information Systems (MIS). It supports worklist integration, DICOM output (DICOM SC, MG CAD SR), and CAD findings as an image overlay. It is also integrated into GE HealthCare's MyBreastAI Suite.

Physician Tip

PowerLook Density Assessment offers an objective and consistent method for breast density categorization, reducing the subjectivity inherent in visual assessments. This standardization can enhance diagnostic confidence, streamline reporting, and facilitate more personalized screening recommendations based on a patient's BI-RADS density. It helps in identifying patients who may require supplemental imaging due to dense breast tissue masking potential cancers. The ease of integration and automated nature can significantly improve workflow efficiency.

The solution is designed for multi-vendor compatibility and seamless integration within existing radiology IT infrastructure, including PACS, RIS/MIS, and reading workstations. It supports standard DICOM output and worklist integration, allowing for efficient incorporation into current clinical workflows and display of results as image overlays or in reports. It is part of iCAD's broader suite of breast health solutions and can be integrated with platforms like GE HealthCare's MyBreastAI Suite.

At a glance

Pricing Contact vendor for pricing.

Deployment On Premise Or Integrated Solution Within Existing Radiology Infrastructure (operates On ICAD's PowerLook® Platform And PowerLook DICOM Server Platform).

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Details

Category	Clinical Decision Support & Reference, Oncology AI, Radiology & Imaging AI
Pricing	Contact vendor for pricing.
Deployment	On-premise or integrated solution within existing radiology infrastructure (operates on iCAD's PowerLook® platform and PowerLook DICOM server platform).
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated FDA clearance K211506 was granted on July 12, 2021, for PowerLook Density Assessment 4.0. It is a software application for mammography exams with synthetic 2D images from Digital Breast Tomosynthesis (DBT), assessing breast tissue composition and providing a BI-RADS® 5th Edition density category.
Integrations
EHR	Not specified
Specialties	Obstetrics & Gynecology, Oncology, Radiology

What the Web Says

PowerLook Density Assessment, offered by iCAD, is generally viewed as a valuable tool for breast density assessment, aiding in personalized screening strategies. It automates a process that can be subjective, providing quantitative results. While praised for its objectivity and integration capabilities, some sources note the need for further clinical validation and the potential for over-reliance on automated systems.

Overall: Positive

Strengths

Automated, objective breast density assessment
Aids in personalized screening and risk assessment
Integrates with existing mammography systems
Reduces inter-reader variability compared to visual assessment
Provides quantitative results for consistent reporting
Supports compliance with breast density notification laws

Limitations

Requires integration and setup within existing IT infrastructure
Potential for over-reliance on automated results without clinical context
Some physicians may prefer their own subjective assessment
Limited direct user reviews from platforms like G2/Capterra (as it's a specialized medical device component)
Ongoing need for further large-scale clinical outcome studies
Cost of implementation and ongoing maintenance

Based on reviews from: iCAD official website and whitepapers, Radiology journals and research articles (e.g., Journal of Digital Imaging, European Radiology), Healthcare IT news and analysis sites, Physician forums and professional society discussions, Medical device review sites (though less direct user reviews for this specific component), Reddit (limited specific discussion, more general breast density topics)

Last updated: 2026-07-18

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Press & Coverage

iCAD, Inc.

iCAD Advances Fight Against Breast Cancer with FDA-cleared, Next-Generation AI Solutions and ProFound Health Partnership with Cascaid Health at RSNA 2024

iCAD will showcase its breast health AI technologies, including the FDA-cleared PowerLook Density Assessment, at RSNA 2024 and announce a partnership with Cascaid Health to expand access to AI-driven breast health solutions.

2024-11

iCAD, Inc.

iCAD To Showcase Five AI-Powered Research Presentations Advancing Breast Cancer Detection, Risk Evaluation, and Breast Arterial Calcification Assessment at ECR 2025

iCAD will present five AI-powered research presentations at ECR 2025, covering advancements in breast cancer detection, risk evaluation, and breast arterial calcification assessment, with PowerLook Density Assessment being FDA cleared, CE Marked, and Health Canada Licensed.

2025-02

The ASCO Post

Changes in AI Mammogram Risk Scores Over Time May Help to Predict Future Breast Cancer - The ASCO Post

New research published in Radiology found that AI-derived breast cancer risk scores from mammograms evolve over time, offering a new era of dynamic risk assessment that performs better than traditional models and breast density alone.

2026-06

AiThority

iCAD's Breast AI Suite Empowers Customers to Lead the Way in Support of FDA's National Breast Density Reporting Standard - AiThority

iCAD's PowerLook Density Assessment is highlighted for its accurate and reproducible breast density assessments, helping clinicians meet the FDA's national breast density reporting standard and personalize screening recommendations.

2023-03

Ferrum Health

Ferrum Health to Offer iCAD's Breast AI Technologies within its Women's Health AI Hub

Ferrum Health partnered with iCAD to integrate ProFound AI for Digital Breast Tomosynthesis (DBT) and PowerLook Density Assessment into its Women's Health AI Hub, aiming to empower radiologists in early breast cancer detection.

2022-11

FirstWord HealthTech

iCAD Announces Compelling New and Real-World Data Demonstrating the Value of ProFound AI to be Presented at RSNA 2021 | FirstWord HealthTech

iCAD announced that new and real-world data on ProFound AI and PowerLook Density Assessment would be presented at RSNA 2021, showcasing the software's ability to automate breast density assessment accurately and reliably.

2021-11

accessdata.fda.gov

iCAD, Inc. July 12, 2021 Ms. Heather Reed Vice President, Quality Assurance and Regulatory Affairs 98 Spit Brook Rd. Suite - accessdata.fda.gov

This FDA document details the 510(k) clearance for PowerLook Density Assessment Version 4.0, a software application intended for use with digital breast tomosynthesis synthesized 2D images to provide ACR BI-RADS Atlas 5th Edition breast density categories.

2021-07

Radiology Today Magazine

Revealing Images - Radiology Today Magazine

Radiology Today discusses how iCAD's PowerLook Density Assessment provides automated, fast, and reproducible breast density assessments, helping radiologists identify patients who may benefit from supplemental screening.

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Videos

Product demos, reviews, and walkthroughs for PowerLook Density Assessment.

Using PowerLook Density Assessment in daily practice

iCAD Inc.

Dr. Laura Dean discusses how PowerLook Density Assessment works

iCAD Inc.

Why Cleveland Clinic uses PowerLook Density Assessment software for objective density assessments

iCAD Inc.

Dr. Laura Dean shares how PowerLook Density Assessment can standardize breast density assessments.

iCAD Inc.

Chirag R. Parghi, MD - Objective density assessments

iCAD Inc.

How iCADu2019s technology is standardizing dense breast assessments at the Cleveland Clinic

iCAD Inc.

View all on YouTube

Frequently Asked Questions

How does PowerLook Density Assessment integrate into our current mammography workflow, and what specific AI functionalities does it offer for breast density classification?

PowerLook Density Assessment seamlessly integrates into existing mammography workflows, including RIS/MIS, PACS, and reading workstations. It leverages deep-learning AI to analyze full-field digital mammography (FFDM) or synthetic 2D/3D images, assessing breast anatomy, tissue dispersion, and texture to objectively categorize breast density according to BI-RADS 5th edition.

What regulatory approvals (e.g., FDA) does PowerLook Density Assessment hold, and how does it ensure compliance with patient data privacy regulations like HIPAA?

PowerLook Density Assessment is FDA cleared, CE Marked, and Health Canada Licensed, indicating it meets specific regulatory standards for medical devices. While specific HIPAA compliance mechanisms are not detailed in the provided information, studies involving the tool have been conducted under IRB approval and in a HIPAA-compliant manner.

How does PowerLook Density Assessment compare in accuracy and efficiency to other automated breast density solutions or traditional radiologist visual assessment methods?

PowerLook Density Assessment aims to provide objective and consistent results, addressing the significant subjectivity and variability found in traditional radiologist visual assessments. It has demonstrated 'moderate' to 'substantial' agreement with expert radiologists, comparable to inter-radiologist agreement. While other automated tools like Volpara and Quantra exist, PowerLook is highlighted as a multi-vendor deep learning solution with high matching accuracy.

What is the typical pricing model for PowerLook Density Assessment, including potential costs for integration, licensing, or per-study usage?

Specific pricing models for PowerLook Density Assessment, such as subscription or per-study fees, are not explicitly detailed in the provided search results. However, it is noted that prices are indicative, pre-tax, and exclude delivery, customs, installation, or activation charges, with variations possible by country and market factors. Integration costs are implied as part of deploying such a solution.

What are the known limitations or potential biases of PowerLook Density Assessment, especially concerning its performance across diverse patient demographics or specific breast characteristics?

A known limitation is that area-based density assessments, which PowerLook utilizes, may not fully capture the three-dimensional nature or depth of dense tissue, potentially leading to an incomplete understanding of masking risk. While the tool aims for consistency, general AI concerns about performance across diverse patient demographics are always relevant, though specific biases for PowerLook in this context were not detailed in the provided snippets. However, validation studies showed high agreement with radiologists, with no disagreement by more than one BI-RADS category.

What clinical evidence and validation studies support the accuracy and reliability of PowerLook Density Assessment's AI-driven classifications?

Clinical performance studies have shown PowerLook Density Assessment accurately estimates percent breast density, dense tissue area, total breast area, and BI-RADS breast density categories across different imaging sensors. It demonstrated 'moderate' to 'substantial' agreement with expert radiologists in these studies. Further validation studies reported an accuracy of 84.6% to 89.7% for classifying into four BI-RADS categories and 94.4% to 97.4% for binary dense/non-dense classification.

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