iCAD Receives FDA Clearance of ProFound Detection Version 4.0 , Revolutionizing Cancer Detection with Enhanced Accuracy and Efficiency

iCAD, a leader in AI-powered cancer detection, has received FDA clearance for its ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT). This next-generation AI solution, powered by advanced deep learning convolutional neural networks (CNN), offers substantial improvements in detecting difficult-to-identify cancers, particularly aggressive subtypes. ProFound Detection Version 4.0 boosts accuracy by 22% compared to previous versions, with notable advancements in identifying cancers within dense breast tissue, invasive lobular cancers, and those smaller than 1 cm. This version also introduces the ability for clinicians to incorporate prior exam data into current screening analyses, enhancing diagnostic precision.

The new version of ProFound Detection promises to improve patient outcomes by reducing false positives and delivering more accurate cancer detection. It provides a 50% improvement in identifying cancers in dense breast tissue and a 60% improvement in detecting invasive lobular cancers. iCAD’s cloud-based deployment also offers scalability and continuous updates, providing ongoing support for facilities and healthcare providers.

Dana Brown, President and CEO of iCAD, emphasized, “With the FDA clearance of ProFound Detection Version 4.0, we set new benchmarks in cancer detection. This solution enhances the ability to identify aggressive cancers, especially in challenging cases, while reducing false positives. It’s a significant step forward in AI-assisted breast cancer diagnosis.” Dr. Chirag Parghi, MD, MBA, Chief Medical Officer at Solis Mammography, noted, “This version addresses the biggest challenges in breast imaging, especially within dense tissue. The improved precision in lesion marking and the ability to integrate prior exams will lead to more efficient and accurate workflows, fostering broader adoption of AI in clinical practice.”