PowerLook® Tomo Detection

by iCAD  · Based in United States → — AI-Powered Breast Tomosynthesis Detection for Enhanced Radiologist Efficiency
Radiology
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Not disclosed
Regulatory Status Disclosed

Overview

PowerLook® Tomo Detection is an advanced, deep learning-based computer-assisted detection (CAD) software device developed by iCAD. It is specifically designed to be used concurrently by radiologists when interpreting digital breast tomosynthesis (DBT) exams. The tool leverages artificial intelligence to automatically analyze each tomosynthesis plane, identifying suspicious areas such as soft tissue densities (masses, architectural distortions, and asymmetries).

The system then blends these detected regions into a 2D synthetic image, providing radiologists with a single, highly sensitive, and enhanced image. This innovative approach helps radiologists more efficiently navigate the often hundreds of images produced by DBT, significantly reducing reading time by an average of 29.2% and up to 37%, without compromising diagnostic performance or accuracy. PowerLook Tomo Detection 2.0 further enhances this by providing a “certainty of finding” score for each detected lesion, indicating the algorithm’s confidence in the malignancy of soft tissue densities and calcifications.

Initially compatible with GE Healthcare’s DBT platforms, later versions (2.0) expanded compatibility to include Hologic and Siemens systems, aiming for a multi-vendor solution. It is a key component of iCAD’s PowerLook Breast Health Solutions suite, which also includes tools for 2D mammography and breast density assessment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Early detection of breast cancer in DBT exams
  • Improving radiologist workflow and efficiency in DBT interpretation
  • Assisting radiologists in navigating large tomosynthesis datasets
  • Enhancing diagnostic confidence in breast imaging
  • Streamlining breast cancer screening and diagnosis

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Not disclosed — Contact vendor for pricing information
DeploymentSoftware integrated with mammography review workstations and digital breast tomosynthesis (DBT) systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Premarket Approval (PMA) P160009 received on March 24, 2017, from the U.S. Food and Drug Administration (FDA) for concurrent-read computer-assisted detection (CAD) software for GE SenoClaire digital breast tomosynthesis exams.
Integrations
EHR Not specified
Specialties Radiology

What the Web Says

PowerLooku00ae Tomo Detection by iCAD is an AI-powered computer-aided detection (CAD) solution designed to assist radiologists in interpreting digital breast tomosynthesis (DBT) exams, also known as 3D mammograms. It aims to improve reading efficiency and diagnostic confidence by analyzing tomosynthesis planes and highlighting suspicious areas on a single 2D synthetic image. The technology has received FDA approval and CE Mark, and studies indicate it can significantly reduce reading time while maintaining or improving sensitivity and specificity in breast cancer detection.

Overall: Positive

Strengths

  • Reduces DBT reading time significantly (average 29-52.7%).
  • Improves radiologists' sensitivity in detecting malignant lesions.
  • Increases specificity, reducing false positives and unnecessary recalls.
  • Enhances radiologists' confidence in interpretations.
  • Streamlines workflow and improves overall reading productivity.
  • Utilizes deep learning and AI for accurate analysis.

Limitations

  • Initially only available for GE Healthcare's DBT platforms, though a multi-vendor solution was expected.
  • Some individual readers may not experience improvements in all metrics (sensitivity, specificity, interpretation time).
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra, with most reviews stemming from iCAD announcements or medical journals.
  • AI systems are intended for assistive or concurrent reading, not as a standalone diagnostic tool.

Based on reviews from: iCAD (icadmed.com), Applied Radiology, Fierce Biotech, PMC (PubMed Central), RSNA Journals (Radiology: Artificial Intelligence, Radiology: Imaging Cancer), BioSpace, Avise Analytics, accessdata.fda.gov, Scribd

Last updated: 2026-07-21

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Press & Coverage

PR Newswire
iCAD Receives FDA Approval For PowerLook Tomo Detection
iCAD announced that its PowerLooku00ae Tomo Detection, a concurrent-read computer-aided detection solution for digital breast 3D tomosynthesis, received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). This solution, built on deep learning technology, aims to improve radiologists' efficiency by reducing reading time without compromising detection rates.
2017-03
Imaging Technology News
iCAD Receives FDA Approval for PowerLook Tomo Detection | Imaging Technology News
iCAD's PowerLook Tomo Detection, a computer-aided detection (CAD) solution for digital breast 3-D tomosynthesis, received FDA Premarket Approval (PMA). The technology uses deep learning to analyze tomosynthesis planes, identify suspicious areas, and blend them into a 2-D synthetic image to improve radiologist efficiency and confidence.
2017-03
Imaging Technology News
iCAD's PowerLook Tomo Detection Experiences Growing Adoption
iCAD Inc. reported increasing customer adoption of its PowerLook Tomo Detection, an AI-driven solution that optimizes digital breast tomosynthesis (DBT) reading efficiency and enhances radiologist confidence. The company highlighted its status as the first and only FDA-approved concurrent-read cancer detection solution for DBT.
2017-12
New Hampshire Tech Alliance
iCAD, Inc.'s PowerLook Tomo Detection Named NH High Tech Council's 2017 Product of the Year
iCAD, Inc.'s PowerLook Tomo Detection was awarded the 2017 Product of the Year by the NH High Tech Council. The FDA-approved tomosynthesis CAD detection software was recognized for its innovative use of deep learning to enhance breast cancer detection and improve reading efficiency.
2017-10
GlobeNewswire
iCAD Granted CE Mark Approval in Europe for PowerLook Tomo Detection 2.0 Artificial Intelligence Solution
iCAD, Inc. announced receipt of CE Mark approval for PowerLook Tomo Detection 2.0, its second deep-learning based computer aided detection solution for digital breast tomosynthesis. This version offers compatibility with Hologic, GE, and Siemens systems, aiming to increase cancer detection rates and improve workflow.
2018-03
AJR Online
Concurrent Computer-Aided Detection Improves Reading Time of Digital Breast Tomosynthesis and Maintains Interpretation Performance in a Multireader Multicase Study
A study published in AJR Online evaluated iCAD's PowerLook Tomo Detection, a concurrent CAD tomosynthesis system, demonstrating that it significantly shortens DBT reading time by 29.2% without negatively affecting radiologist performance in detecting malignant lesions.
2022-01
RSNA Journals
AI-enhanced Mammography With Digital Breast Tomosynthesis for Breast Cancer Detection: Clinical Value and Comparison With Human Performance | Radiology: Imaging Cancer - RSNA Journals
A recent study highlighted that concurrent reading with CAD enhancement by PowerLook Tomo Detection (iCAD) resulted in 23.5% faster reading time and noninferior performance compared with radiologist interpretation in breast cancer detection.
2024-07
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 review of FDA-cleared AI-based CADe/x tools for screening DBT includes PowerLook Tomo Detection 2.0 (iCAD), noting its multireader, multicase study results showing improved AUC and case-level sensitivity.
2024-08

Videos

Product demos, reviews, and walkthroughs for PowerLook® Tomo Detection.

View all on YouTube

Frequently Asked Questions

PowerLooku00ae Tomo Detection is built on a flexible DICOM platform designed for seamless integration with existing image modalities, mammography review workstations, PACS, and image storage systems. It processes digital breast tomosynthesis (DBT) images to generate a CAD-enhanced 2D synthetic image, which radiologists use to efficiently identify suspicious areas and navigate through the extensive DBT datasets.
The system employs deep learning algorithms that automatically analyze each tomosynthesis plane to identify suspicious soft tissue densities, such as masses, architectural distortions, and asymmetries. These identified areas are then blended into a 2D synthetic image, providing radiologists with an enhanced view to optimize reading efficiency and improve confidence in breast cancer detection.
PowerLooku00ae Tomo Detection received U.S. FDA Premarket Approval in March 2017 and CE Mark approval in April 2016, along with Health Canada approval. The software complies with regulatory requirements including EN ISO 13485:2012 and FDA 21 CFR Part 820 (Quality System Regulation), ensuring adherence to medical device quality and safety standards.
Clinical studies have demonstrated that using PowerLooku00ae Tomo Detection concurrently with radiologist interpretation can lead to a significant reduction in reading time, averaging 29.2%, without compromising diagnostic performance or accuracy. While other AI solutions exist, PowerLooku00ae Tomo Detection has been shown to maintain or improve radiologist performance compared to traditional interpretation alone.
Specific details regarding the pricing model, long-term costs, or direct return on investment (ROI) for PowerLooku00ae Tomo Detection are not available in the provided information. However, AI solutions like this are generally marketed with the potential for strong ROI through increased efficiency, fewer recalls, and enhanced diagnostic confidence.
Initially, PowerLooku00ae Tomo Detection was primarily designed to detect soft tissue densities and not calcifications, though later versions expanded detection capabilities. The software may also potentially increase false-positive rates, which could lead to additional imaging, radiation exposure, or patient anxiety.

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View company profile →

Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed PowerLook® Tomo Detection

Funded through the company that built this tool.

HealthpointCapital
PE T3
New York, United States
$25M+
HealthpointCapital is a New York-based private equity firm with a long track record of investing in Israeli medtech, focused exclusively on orthopedic,…
Medical Devices / MedTech
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