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iCAD's ProFound Detection 4.0 Receives FDA Clearance for Enhanced Breast Cancer Detection

9 months ago2 min read

Key Insights

  • iCAD's ProFound Detection Version 4.0, an AI-powered solution for digital breast tomosynthesis, has received FDA clearance, enhancing cancer detection and specificity.

  • The new version demonstrates a 6.3% improvement in AUC, leading to better identification of aggressive cancers and a reduction in false positives.

  • ProFound Detection 4.0 offers a 22% overall improvement in detecting challenging cancer subtypes, including a 50% improvement in dense breast tissue.

iCAD, Inc. has announced that its ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) has received FDA clearance. This next-generation AI solution, leverages advanced deep learning convolutional neural networks (CNN) to improve cancer detection and specificity.
The AI solution demonstrated a 6.3% improved area under the receiver operating characteristic curve (AUC) compared to the previous version. This enhancement allows for better identification of aggressive cancers that are typically hard to find, while simultaneously reducing the occurrence of false positives.

Enhanced Detection Capabilities

Compared to the previous version 3, ProFound Detection Version 4.0 provides a 22% overall improvement in detecting some of the most challenging and aggressive cancer subtypes:
  • 50% improvement in identifying cancers within dense breast tissue
  • 60% improvement in identifying invasive lobular cancers
  • 21% improvement in detecting invasive cancers
  • 38% improvement in identifying cancers smaller than 1 cm

Prior Exam Integration

A significant advancement in ProFound Detection Version 4.0 is the ability for clinicians to incorporate a prior exam into the AI analysis. By integrating prior imaging data, the software aims to provide greater precision and insight, further enhancing clinical decision-making.

Expert Commentary

"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."
Dr. Chirag Parghi, MD, MBA, Chief Medical Officer at Solis Mammography, added, "ProFound Detection Version 4.0 will dramatically improve breast cancer detection. 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."
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