Summary: The FDA has cleared iCAD’s ProFound Detection Version 4.0, an AI-powered tool for Digital Breast Tomosynthesis, which improves cancer detection and specificity, reduces false positives, and offers clinicians the option to incorporate prior exams for enhanced accuracy.

Key Takeaways

  • FDA clearance: ProFound Detection Version 4.0 has received FDA clearance, enabling its use in Digital Breast Tomosynthesis (DBT) to improve breast cancer detection.
  • Improved detection and specificity: The AI solution shows significant improvements in cancer detection, with specific gains in detecting dense tissue, invasive lobular cancers, and small tumors, and reduces false positives.
  • Enhanced clinical workflow: Version 4.0 allows clinicians to incorporate prior exams into current analyses, supporting more accurate, context-driven decision-making in breast cancer screening.

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The FDA has cleared iCAD, Inc.’s ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT). This AI solution, using deep learning convolutional neural networks, improves cancer detection and specificity with a 6.3% increase in the area under the receiver operating characteristic curve over the previous version, aiding in the identification of aggressive cancers and reducing false positives. Version 4.0 also enables clinicians to incorporate prior exams into the current analysis.

Early Detection of Invasive and Small Tumors

Compared to version 3, ProFound Detection Version 4.0 shows a 22% improvement in detecting certain cancer subtypes, including:

  • 50% improvement in detection in dense breast tissue,
  • 60% improvement in identifying invasive lobular cancers,
  • 21% increase 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,” says iCAD President and CEO Dana Brown. “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.”

“ProFound Detection Version 4.0 will dramatically improve breast cancer detection,” adds Chirag Parghi, MD, 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.”

Reduces False Positives 

ProFound Detection Version 4.0 also reduces false positives with an 18% improvement in cases without lesion marks, including:

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

ProFound Detection Version 4.0 allows clinicians to incorporate prior exams into the AI analysis, aligning with radiologists’ approach of using historical context in screenings. This feature provides greater precision and supports clinical decision-making.