FDA Clears iCAD’s ProFound Detection Version 4.0

iCAD Inc.’s ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) has received U.S. Food and Drug Administration (FDA) clearance.

The next-generation AI solution, trained using advanced deep learning convolutional neural networks (CNN), offers advancements in cancer detection and specificity, achieving a 6.3% improved area under the receiver operating characteristic curve (AUC) over prior version, significantly improving the identification of hard-to-find and aggressive cancers while reducing false positives, according to iCAD. Additionally, this version introduces an option for clinicians to incorporate a prior exam into a current exam’s ProFound Detection analysis.

“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,” iCAD President/CEO Dana Brown said. “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.”

With more than 20 years of innovation and experience, iCAD was the first to introduce an FDA-cleared AI solution for DBT in 2016. ProFound Detection Version 4.0 now extends that legacy by offering enhancements in detection and precision. ProFound Detection Version 4.0 is now available for implementation in the United States; additional global and vendor-specific regulatory expansions are anticipated this year.

Beyond its enhanced clinical performance, ProFound Detection Version 4.0 presents substantial growth potential for iCAD. As existing and new customers upgrade to this latest version and adopt cloud-based deployment and subscription programs, iCAD anticipates steady growth in annual recurring revenue. This strategic shift to the cloud enables facilities to remain at the forefront of AI advancements while benefiting from enhanced scalability, continuous updates, and streamlined operational efficiency.

Compared to previous version 3, ProFound Detection Version 4.0 provides a 22% overall improvement in detecting some of the most challenging and aggressive cancer subtypes, including:

• A 50% improvement in identifying cancers within dense breast tissue
• A 60% improvement in identifying invasive lobular cancers
• A 21% improvement in detecting invasive cancers, and
• A 38% improvement in identifying cancers smaller than 1 cm

“ProFound Detection Version 4.0 will dramatically improve breast cancer detection,” stated Dr. Chirag Parghi, M.D., MBA, chief medical officer at Solis Mammography. “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.”

Along with improved cancer detection capabilities, ProFound Detection Version 4.0 delivers more precise lesion marking, with an 18% improvement in cases with no marks, reducing potential false positives by enhanced specificity performance. This includes:

• 20% fewer marks related to vascular calcifications, and
• 51% fewer marks related to non-vascular calcifications

ProFound Detection Version 4.0 enables clinicians to incorporate a prior exam into its AI analysis and case-score/lesion assessment on the current case, emulating the approach radiologists take when interpreting current screening exams with historical context. By integrating prior imaging data, the software provides greater precision and insight, further enhancing clinical decision-making.

iCAD Inc. provides clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’s ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment, and risk evaluation. Used by thousands of providers serving millions of patients, ProFound is available in more than 50 countries. In the last five years, iCAD estimates reading more than 40 million mammograms worldwide, with nearly 30% being tomosynthesis.