iCad, Inc. (Nasdaq:ICAD) has announced that its ProFound Detection version 4.0, an AI-powered solution for digital breast tomosynthesis (DBT), has received FDA clearance. This next-generation AI solution, trained using deep learning convolutional neural networks (CNN), offers advancements in cancer detection and specificity, improving the identification of hard-to-find and aggressive cancers while reducing false positives.
Enhanced Cancer Detection Capabilities
Compared to the previous ProFound Detection version, version 4.0 provides a 22% overall improvement in detecting some of the most challenging and aggressive cancer subtypes. Notably, it demonstrates a 50% improvement in identifying cancers within dense breast tissue, a particularly challenging area for detection. The technology also shows a 60% better identification of invasive lobular cancers, 21% for detecting invasive cancers, and 38% in cancers smaller than 1 cm.
Precision and Efficiency
The system delivers more precise lesion marking, with an 18% overall improvement in cases with no marks. This enhancement reduces false positives, providing clinicians with a more accurate and efficient AI concurrent-reader solution.
Executive Perspective
"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," said Dana Brown, president and CEO of iCAD. "This groundbreaking 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."
Future Expansion
iCad now offers the technology in the U.S. and expects to add more global and vendor-specific regulatory expansions in 2025.
