NASHUA, N.H., November 12, 2024 — iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”) a global leader in clinically proven AI-powered cancer detection solutions, announced today that its ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) has received clearance from the U.S. Food and Drug Administration (FDA). This 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. Additionally, this version introduces an option for clinicians to incorporate a prior exam into a current exam’s ProFound Detection analysis.
With over 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 pioneering legacy by offering enhancements in detection and precision. With today’s FDA clearance, ProFound Detection Version 4.0 is now available for implementation in the U.S. Additional global and vendor-specific regulatory expansions are anticipated through 2025.
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 (ARR). 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.
Ad Statistics
Times Displayed: 42734
Times Visited: 147 GE HealthCare’s Repair Center Solutions are an ideal complement to your in-house service team. We service a broad range of mobile devices, including monitors and cardiology devices, parts, and portable ultrasound systems and probes.
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:
50% improvement in identifying cancers within dense breast tissue,
60% improvement in identifying invasive lobular cancers,
21% improvement in detecting invasive cancers, and
38% improvement in identifying cancers smaller than 1 cm
“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.”
