V4 Available in U.S. with New FDA Clearance
With over 20 years of artificial intelligence innovation and experience, iCAD was the first to introduce an FDA-cleared AI solution for Digital Breast Tomosynthesis (DBT) in 2016. ProFound Detection V4.0 now extends that pioneering legacy to its fourth generation AI using the latest in deep learning neural network technologies, offering impressive enhancements in detection and specificity.
iCAD’s ProFound Detection V4 empowers radiologists with enhanced diagnostic precision and confidence, offering unparalleled value to both clinicians and patients in finding breast cancer earlier.
With its FDA clearance, ProFound Detection V4 is now available in the U.S. Additional global and vendor-specific regulatory expansions are anticipated through 2025.
ProFound Detection Version 4.0
“With FDA clearance of ProFound Detection Version 4.0, iCAD continues to set new benchmarks in cancer detection, especially in the most challenging cases where accurate and early detection is critical. This fourth generation of our AI solution not only enhances detection for cancers feared most by even the expert fellowship-trained breast radiologists, but also reduces the burden of potential false positives, thereby providing clinicians with a highly precise and efficient AI concurrent-reader solution. We believe this advancement strengthens our competitive position and represents a powerful driver for long-term growth.”
Dana Brown
President and CEO, iCAD
Improved Accuracy
ProFound Detection V4 improves sensitivity and accuracy, particularly for challenging cancer cases. Compared to ProFound AI Detection V3, it boasts an overall 22% greater detection of aggressive cancers1, including:
- 50% improvement in dense breast detection
- 60% higher sensitivity for invasive lobular cancers
- 21% better detection of invasive cancers
- 38% improvement for cancers under 1 cm
These improvements help uncover critical cancers earlier, especially in dense tissue, which can hide cancer from view in the mammogram.
Case Study: Accuracy in Action
In this case, a 46-year-old woman with extremely dense breasts, pathology found Grade 2 invasive ductal carcinoma and Grade 2 DCIS.
ProFound Detection: On her screening mammogram, ProFound Detection V4 identified a High case score and lesion mark of 73 and a Density rating of D-.
ProFound AI Breast Health Suite could have assisted with detection of this malignancy, helping ensure cancer can’t hide.
Improved Precision
ProFound Detection V4 enhances radiologists’ workflow by delivering more precise lesion markings with an 18% improvement in cases with no marks1.
Reduces False Positives
Staying focused on the areas that matter most is critical for radiologists. ProFound Detection V4 provides a significant reduction in unnecessary lesion marks1, including:
- 20% fewer vascular calcification marks
- 51% fewer non-vascular calcifications
This improved precision not only improves efficiency but also reduces patient anxiety caused by unnecessary recalls.
Refines Lesion Scores
Enhanced ipsilateral correlation further refines lesion scores by comparing observations across views, leading to fewer unnecessary marks and enabling radiologists to focus on actionable findings.
Case Study: Precision in Action
A non-cancer case highlights the precision of ProFound Detection V4. Version 3 identified three benign areas, which included two vascular marks and one soft tissue density.
Version 4 reduced false positives to a single mark—removing all vascular marks—while preserving a soft tissue relevant finding for the radiologist to evaluate.
Integrating Prior Exams
NEW! Incorporating prior scans into its analysis, ProFound Detection V4 mirrors the radiologist’s natural workflow. This feature evaluates lesion changes over time and removes low-risk marks when no significant changes are detected. The ability to compare current scans with historical data improves diagnostic accuracy and supports better-informed clinical decisions.
“ProFound Detection Version 4.0 will dramatically improve breast cancer detection. The newest version’s ability to detect subtle invasive cancers, especially within dense breast tissue, addresses one of the biggest challenges in breast imaging today. The improved precision in ProFound Detection’s lesion marking combined with the option to incorporate prior exams allows for improved clinical accuracy and more efficient reading workflows. Collectively, these upgrades will enhance the AI-enriched interpretation experience leading to meaningful adoption of AI.”
Chirag Parghi, MD, MBA
Chief Medical Officer at Solis Mammography
Built for Her. AI-Powered for You.
By uncovering hard-to-detect cancers while reducing unnecessary findings, ProFound Detection V4 offers:
Radiologists
A powerful, precise solution delivering
faster, more accurate cancer detection
and decision support.
Patients
Reduced anxiety, clearer more accurate
results, and increased trust in her breast cancer screening experience.
iCAD continues to lead the way in AI-driven breast imaging solutions, and ProFound Detection Version 4.0 exemplifies its commitment to creating a world where cancer can’t hide.
You don’t have to change for us! Using your existing PACS and other systems, and deploying on your cloud, our cloud, or on-premises, we’ve got you covered. Let’s connect to demonstrate the power of ProFound Detection Version 4.0 today!
Ready to upgrade or migrate to ProFound AI?
Schedule your consultation today.
References:
1. Compared to prior Version 3.0. ProFound Detection not available in all geographies.