iCad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis (DBT).
Nashua, New Hampshire-based iCad trained its next-generation AI solution using deep learning convolutional neural networks (CNN). It offers advancements in cancer detection and specificity, improving the identification of hard-to-find and aggressive cancers. The technology also reduces false positives and introduces a new option for clinicians to incorporate a prior exam into its analysis.
The latest version builds upon iCad’s previous DBT solutions. The first of those received FDA clearance in 2016. Version 4.0 now extends that by offering enhancements in detection and precision. iCad now offers the technology in the U.S. and expects to add more global and vendor-specific regulatory expansions in 2025.
Compared to the previous ProFound Detection version, this one provides a 22% overall improvement in detecting some of the most challenging and aggressive cancer subtypes, the company says. That includes a 50% improvement in identifying cancers within dense breast tissue.
iCad also reports 60% better identification of invasive lobular cancers, 21% for detecting invasive cancers and 38% in cancers smaller than 1 cm. The system also delivers more precise lesion marking, with an 18% overall improvement in cases with no marks. That includes reducing false positives.
“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, 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.”
