About
iCAD ProFound AI, now part of DeepHealth, is an advanced artificial intelligence platform purpose-built for breast cancer detection and screening optimization. Designed for radiologists and healthcare providers, it offers a comprehensive suite—ProFound Breast Health Suite—that combines three core capabilities: Cancer Detection, Density Assessment, and Risk Evaluation. The Cancer Detection module leverages a 5th-generation AI algorithm trained on millions of mammographic images to find more invasive and interval cancers earlier, reduce recalls, and cut reading time in half. It supports both 2D and 3D mammography and is available in the US and globally. The Density Assessment module provides objective, consistent breast density scoring, helping clinicians inform personalized treatment plans. Since dense breast tissue can elevate cancer risk up to 4x, accurate density evaluation is critical to patient care. The Risk Evaluation module is the world's first image-based risk model, reported to be 2.4x more accurate than traditional models. It helps identify women at high risk of developing cancer before or at their next screening, enabling earlier intervention. ProFound AI integrates into existing radiology workflows with rapid implementation, flexible deployment, and seamless compatibility with trusted systems. Backed by decades of clinical research, thousands of clinical sites, and over 89 peer-reviewed publications, iCAD ProFound AI is a trusted tool for improving breast cancer outcomes worldwide.
Key Features
- AI Cancer Detection: Finds more invasive and interval cancers earlier in both 2D and 3D mammography, cutting radiologist reading time in half while reducing unnecessary recalls.
- Breast Density Assessment: Delivers objective, reliable, and consistent breast density scoring to inform personalized treatment plans and patient communication.
- Image-Based Risk Evaluation: The world's first image-based risk model, 2.4x more accurate than traditional models, identifies women at high risk before or at their next screening.
- Seamless Workflow Integration: Rapid implementation with flexible and secure deployment options that integrate into existing clinical systems and radiology workflows.
- Regulatory Clearances: FDA Cleared, CE Marked, and Health Canada Licensed, ensuring compliance and trust across multiple global healthcare markets.
Use Cases
- Radiology departments using AI to improve early breast cancer detection rates in routine mammography screenings.
- Healthcare systems seeking to reduce radiologist reading time and improve throughput without compromising diagnostic accuracy.
- Clinicians needing standardized, objective breast density assessments to guide personalized patient care and supplemental screening recommendations.
- Hospitals and imaging centers looking to identify high-risk patients earlier using image-based AI risk stratification.
- Healthcare organizations in 50+ countries seeking FDA Cleared, CE Marked AI tools to enhance mammography programs and patient outcomes.
Pros
- Clinically Validated: Backed by 89+ clinical studies, millions of training images, and a 5th-generation AI algorithm developed over years of research.
- Improves Early Detection: Enables earlier identification of breast cancer, contributing to the 99% five-year survival rate associated with early-stage diagnosis.
- Global Availability: Available in over 50 countries with regulatory clearances from multiple major health authorities worldwide.
- Reduces Radiologist Workload: Cuts mammogram reading time in half, helping radiologists manage higher screening volumes without sacrificing accuracy.
Cons
- Enterprise Pricing: Designed for healthcare organizations and hospital systems; pricing is not publicly available and requires a demo request, making it inaccessible for small clinics.
- Risk Tool Not Yet FDA Cleared: ProFound AI Risk is currently only available in the US for investigational use and is not yet FDA Cleared, limiting its clinical application domestically.
- Implementation Dependency: Requires integration with existing mammography and radiology systems, which may involve IT lift and vendor coordination for deployment.
Frequently Asked Questions
What is iCAD ProFound AI?
iCAD ProFound AI is a suite of AI-powered solutions for breast cancer detection, density assessment, and risk evaluation used by radiologists during mammography screenings.
Is iCAD ProFound AI FDA Cleared?
Yes, the cancer detection and density assessment modules are FDA Cleared, CE Marked, and Health Canada Licensed. The Risk Evaluation module is CE Marked and Health Canada Licensed but is currently only available in the US for investigational use.
What types of mammography does iCAD support?
iCAD ProFound AI supports both 2D and 3D mammography (digital breast tomosynthesis), and is available in the US and globally across various countries.
How accurate is ProFound AI compared to traditional models?
The ProFound AI Risk model is reported to be 2.4x more accurate than traditional risk models, and the detection algorithm is designed to find more invasive and interval cancers while reducing false positives.
How does iCAD integrate into existing clinical workflows?
iCAD offers rapid implementation with flexible and secure deployment options that seamlessly connect to existing radiology systems, PACS, and clinical infrastructure.
