ProFound Detection

by iCAD, Inc.  · Based in United States → — A screening revolution has arrived. The difference is ProFound.
Oncology Radiology
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Regulatory Status Disclosed

Overview

ProFound Detection by iCAD is an AI-powered computer-assisted detection and diagnosis (CAD) software device designed for digital breast tomosynthesis (DBT) images. It utilizes advanced deep learning convolutional neural networks to analyze each tomosynthesis image, detecting malignant soft-tissue densities (masses, architectural distortions, and asymmetries) and calcifications. The system provides lesion-specific scores (0-100) and case scores, which assist interpreting physicians in quickly identifying suspicious areas and prioritizing caseload. ProFound Detection Version 4.0 offers significant advancements in cancer detection and specificity, including a 22% overall improvement in detecting challenging and aggressive cancer subtypes and an 18% improvement in cases with no marks, thereby reducing false positives. This version also introduces the capability for clinicians to incorporate prior exams into the current analysis, emulating radiologists’ approach to historical context in screenings.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered cancer detection for Digital Breast Tomosynthesis (DBT) and 2D mammography
  • Detects malignant soft-tissue densities (masses, architectural distortions, asymmetries) and calcifications
  • Utilizes deep learning convolutional neural networks
  • 22% overall improvement in detecting challenging and aggressive cancer subtypes (V4.0 vs V3.0)
  • 18% improvement in cases with no marks, reducing false positives (V4.0 vs V3.0)
  • Option to incorporate prior exams into current AI analysis
  • Provides lesion scores (0-100) and case scores for malignancy confidence
  • Color-coded lesion marks and scorecard for improved readability
  • Limits number of marks per view (e.g., three per view by default)
  • Multi-vendor compatibility

Use Cases

  • Early breast cancer detection in digital breast tomosynthesis (DBT)
  • Assisting radiologists in interpreting mammograms concurrently
  • Prioritizing caseload based on AI-generated case scores
  • Reducing radiologist reading time by over 52.7%
  • Improving diagnostic accuracy and performance for breast imaging professionals
  • Enhancing clinical decision-making by providing precise and efficient AI concurrent-reader solution

What Physicians Need to Know

Key Capabilities
Deep-learning AI for breast cancer detection in 2D mammography and Digital Breast Tomosynthesis (DBT), identifying soft tissue densities and calcifications. Version 4.0 significantly improves detection of challenging cancer subtypes (e.g., 50% in dense breast tissue, 60% in invasive lobular cancers) and reduces false positives by enhancing lesion marking precision. It provides 'Certainty of Finding' lesion scores and 'Case Scores' to prioritize caseload and supports incorporating prior exams for enhanced clinical decision-making.
Clinical Utility
Increases cancer detection rates (23-27% or more, up to 65% for general radiologists) and reduces recall rates by 7.2%. It improves diagnostic accuracy and performance for radiologists, aiding in earlier cancer detection and potentially better patient outcomes. Particularly effective in dense breast tissue and for identifying small, invasive cancers.
Integration Options
Seamless integration into standard PACS reading environments with multi-vendor compatibility. Offers both local deployment on dedicated hardware and cloud-based deployment via ProFound Cloud (built on Google Cloud Platform), enabling enhanced scalability and continuous updates. Collaboration with Microsoft integrates ProFound AI into the Precision Imaging Network and PowerScribe for automated radiology reporting.
Compliance Status
ProFound Detection V4 is FDA-cleared (510(k) cleared, Class II). ProFound AI V3 is FDA-cleared, CE Marked (MDD Class IIa), and Health Canada Licensed. ProFound AI for 2D Mammography is CE Marked but not FDA Cleared in the US. ProFound AI Risk is CE Marked and Health Canada Licensed, available for investigational use only in the U.S.
Pricing Model
Specific pricing details are not publicly disclosed. However, iCAD is transitioning towards cloud-based deployment and subscription programs, indicating a shift to a Software-as-a-Service (SaaS) model for anticipated recurring revenue growth.
User Experience
Features improved readability with a configurable option to limit to three color-coded lesion marks per 3D view, indicating low, intermediate, or high suspicion. The ProFound Scorecard provides a color-coded summary for detection, density, and risk, streamlining the diagnostic process and enhancing radiologist confidence. It also significantly reduces radiologist reading time by over 52.7%.
Support Quality
iCAD offers a team of experts for support, particularly for cloud deployment, and provides customer success contact for upgrades. Specific details on support channels or response times are not publicly available.
Implementation Complexity
Designed for rapid implementation and swift go-live with flexible and secure deployment options for smooth IT adoption. Cloud-based deployment minimizes the need for extensive on-premises infrastructure and offers processing times of 1-10 minutes, with cloud processing being over 50% faster than traditional on-premises solutions.
Evidence Base
Clinically proven, trained on over 20 million images, 88,000 cases, and 13,500 biopsied cancers from 130 centers. Supported by numerous peer-reviewed studies demonstrating improved cancer detection rates, reduced recalls, and decreased reading times. ProFound AI Risk has shown superior accuracy compared to traditional risk models.
Physician Tip

ProFound Detection offers a powerful AI concurrent-reader solution, especially beneficial for Digital Breast Tomosynthesis (DBT) interpretation. Leverage the 'Certainty of Finding' and 'Case Scores' for efficient caseload prioritization and to quickly identify suspicious lesions. The color-coded lesion marks and scorecard in Version 4.0 enhance readability, allowing for rapid assessment of suspicion levels. Incorporating prior exams into the AI analysis can provide greater precision, emulating a radiologist's comprehensive review. This tool is particularly valuable for detecting subtle invasive cancers in dense breast tissue and for improving overall diagnostic accuracy and workflow efficiency.

ProFound Detection is designed for seamless integration into existing PACS and reading environments, offering multi-vendor compatibility. The availability of ProFound Cloud, built on Google Cloud Platform, provides a scalable and continuously updated SaaS solution. Furthermore, the collaboration with Microsoft to integrate into the Precision Imaging Network and PowerScribe will enable automated radiology reporting and streamlined workflows for users of those platforms.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact vendor for pricing — Subscription-based; cloud-based deployment programs anticipated
DeploymentLocally on dedicated hardware; cloud-based deployment and subscription programs are anticipated.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ProFound Detection Version 4.0 received FDA clearance (K240417) on November 8, 2024, for use with Digital Breast Tomosynthesis (DBT) to detect malignant soft-tissue densities and calcifications.
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

ProFound Detection, offered by iCAD, is a mammography CAD (Computer-Aided Detection) system designed to assist radiologists in identifying potential breast cancers. Reviews indicate it is widely used in clinical settings and aims to improve early detection rates by highlighting suspicious areas on mammograms, though its effectiveness and impact on workflow are subjects of ongoing discussion.

Overall: Mixed

Strengths

  • Aids in early detection of breast cancer.
  • Widely adopted and integrated into many mammography workflows.
  • Can reduce false negatives by drawing attention to subtle abnormalities.
  • May improve radiologist confidence in some cases.
  • Regularly updated with new versions and features.
  • Backed by clinical studies (though interpretation varies).

Limitations

  • Can lead to an increase in false positives, potentially causing unnecessary callbacks and biopsies.
  • May contribute to 'alert fatigue' for radiologists due to numerous highlighted areas.
  • Some argue it doesn't significantly improve diagnostic accuracy over experienced radiologists alone.
  • Cost of implementation and ongoing maintenance can be substantial for healthcare providers.
  • Integration challenges with existing PACS and RIS systems have been reported.
  • Debate exists regarding its true impact on patient outcomes versus increased workload.

Based on reviews from: Radiology journals and research papers (e.g., Journal of the American College of Radiology, Radiology), Healthcare IT news outlets, Physician forums and discussions, G2 (general tech reviews, though specific to healthcare software), Capterra (general tech reviews, though specific to healthcare software), Reddit (discussions in medical or technology subreddits)

Last updated: 2026-07-19

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Press & Coverage

Imaging Technology News
iCAD's ProFound Detection Version 4.0 Gets FDA Clearance
iCAD announced FDA clearance for its ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT), an AI solution offering improved cancer detection and specificity, including a 22% overall improvement in detecting challenging cancer subtypes. This version also allows clinicians to incorporate prior exams into the current analysis.
2024-11
AuntMinnie
iCAD secures FDA clearance for ProFound Detection 4.0
iCAD received FDA clearance for ProFound Detection 4.0, which was trained using advanced deep-learning convolutional neural networks and demonstrated a 22% overall improvement in detecting aggressive cancer subtypes. The updated software also offers more precise lesion marking and the ability to incorporate prior exams into the AI analysis.
2024-11
Axis Imaging News
FDA OKs iCAD's ProFound Detection 4.0
The FDA has cleared iCAD's ProFound Detection Version 4.0 for Digital Breast Tomosynthesis, an AI solution that enhances cancer detection and specificity while reducing false positives. It also allows for the integration of prior exams into the current analysis for improved accuracy.
2024-11
iCAD, Inc. (Press Release)
iCAD's ProFound Detection Version 4.0 Gains FDA Clearance
iCAD announced FDA clearance for ProFound Detection Version 4.0 for DBT, highlighting its 22% overall improvement in detecting challenging cancer subtypes and the new feature allowing clinicians to incorporate prior exams. This next-generation AI solution is now available in the U.S. with further global expansions anticipated.
2024-11
MD+DI Online
iCAD Teams up with Microsoft to Tackle Breast Cancer
iCAD is collaborating with Microsoft to integrate its AI-powered mammography solutions, including the ProFound Breast Health Suite, onto Microsoft's Precision Imaging Network. This partnership aims to expand the reach of iCAD's technology and streamline mammography reporting through Microsoft's PowerScribe platform.
2025-04
Medical Product Outsourcing
FDA Clears iCAD's ProFound Detection Version 4.0
iCAD's ProFound Detection Version 4.0 has received FDA clearance, offering significant improvements in detecting challenging and aggressive cancer subtypes, including a 50% improvement in dense breast tissue. The latest version also enhances lesion marking precision and allows for the incorporation of prior exams.
2025-01
iCAD, Inc. (Press Release)
iCAD Releases Enhanced ProFound Detection Workstation Features to Streamline Mammogram Interpretation for Radiologists
iCAD announced new workstation features for ProFound Detection, including limiting lesion marks to the three highest-scoring lesions and color-coding lesion marks and ProFound Scorecards. These enhancements aim to improve radiologists' interpretability and efficiency in mammogram interpretation.
2024-03
RSNA Journals
Patient Characteristics Impact Performance of AI Algorithm in Interpreting Negative Screening Digital Breast Tomosynthesis Studies
This peer-reviewed article discusses how patient characteristics influence the performance of AI algorithms, specifically ProFound AI 3.0, in interpreting negative screening Digital Breast Tomosynthesis studies. The study highlights the algorithm's FDA approval for breast cancer detection in DBT examinations.
2024-05

Videos

Product demos, reviews, and walkthroughs for ProFound Detection.

View all on YouTube

Frequently Asked Questions

ProFound Detection is designed for seamless integration into existing radiology workflows, supporting multi-vendor compatibility and various PACS systems. It functions as a concurrent-read solution, providing radiologists with AI-powered analysis and scores that assist in clinical decision-making and case prioritization.
ProFound Detection supports both 2D mammography and 3D Digital Breast Tomosynthesis (DBT), offering solutions for cancer detection, density assessment, and personalized risk evaluation. Clinically, it has been shown to increase cancer detection rates, particularly for aggressive and subtle cancers in dense breast tissue, while also reducing false positives and improving reading efficiency for radiologists.
Yes, ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) has received clearance from the U.S. Food and Drug Administration (FDA). This clearance signifies that the device is deemed safe and effective for its intended use in assisting physicians with breast cancer detection in the U.S.
While specific details for ProFound Detection's HIPAA compliance are not explicitly detailed in all search results, healthcare AI solutions generally adhere to HIPAA by implementing robust data de-identification methods, encryption, access controls, and requiring Business Associate Agreements (BAAs) with covered entities. This ensures the protection of Protected Health Information (PHI) during processing and analysis.
While ProFound Detection significantly enhances detection, it is an assistive tool and not a replacement for human interpretation. Like all AI, its performance is dependent on the data it was trained on, and continuous updates are necessary to maintain optimal performance. The 'ProFound AI Risk' solution, for instance, is not FDA cleared and is for investigational use only in the US.
One notable alternative mentioned in comparative studies is Transpara, another deep learning-based AI system for mammography with digital breast tomosynthesis. Other general breast imaging techniques like ultrasound and MRI also exist, though they have different applications and limitations compared to AI-enhanced mammography.
Specific pricing models for ProFound Detection are not publicly detailed in the search results. However, similar healthcare AI solutions are often priced based on factors like credit-based usage, annual licenses, or per-study fees, with enterprise packages tailored to an organization's specific needs and volume.

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

Investors who backed ProFound 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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