iCAD’s new AI breast cancer detection technology receives FDA approval

iCAD’s new AI breast cancer detection technology receives FDA approval

USA – iCAD, Inc., a leader in AI-powered cancer detection technology, has announced that its latest AI solution, ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT), has received U.S. FDA clearance.

This next-generation software is built on deep learning convolutional neural networks (CNN), marking a significant advancement in breast cancer detection with a 6.3% improvement in the area under the receiver operating characteristic curve (AUC).

The new version promises enhanced detection accuracy, particularly for aggressive and hard-to-find cancers, while also reducing false positives.

philippinespharmahealthcare advert 3

With FDA clearance now in place, ProFound Detection Version 4.0 is available for U.S. implementation, and additional international regulatory approvals are anticipated by 2025.

This cutting-edge AI solution enables clinicians to analyze current exams with the option to incorporate prior exam data, which further refines the precision of clinical assessments.

Compared to its previous version, ProFound Detection Version 4.0 offers substantial advancements in detecting complex cancer cases.

This includes a 50% enhancement in identifying cancers within dense breast tissue, a 60% improvement in detecting invasive lobular cancers, a 21% increase in identifying invasive cancers, and a 38% rise in detecting 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 of iCAD.

This breakthrough “not only enhances detection for cancers feared most by even 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.

The latest version also significantly improves lesion marking, enhancing the specificity of its results by marking 20% fewer vascular calcifications and 51% fewer non-vascular calcifications.

This contributes to an 18% improvement in cases with no marks, helping to reduce potential false positives and unnecessary follow-up testing.

Dr. Chirag Parghi, Chief Medical Officer at Solis Mammography, noted the benefits of ProFound Detection Version 4.0 for clinical workflow.

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,” he said.

Collectively, these upgrades will enhance the AI-enriched interpretation experience leading to meaningful adoption of AI.”

ProFound Detection Version 4.0 will be featured at the 2024 Radiological Society of North America (RSNA) annual meeting in Chicago, where iCAD will showcase its full range of capabilities designed to transform cancer detection.