iCAD ($ICAD) Receives FDA clearance for ProFound Detection Version 4.0

iCAD, Inc. (NASDAQ: ICAD) 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).

Significant data points and key information

  • The state-of-the-art AI solution, developed with cutting-edge deep learning convolutional neural networks (CNN), enhances cancer detection and specificity.
  • It achieves a 6.3% increase in the area under the receiver operating characteristic curve (AUC) compared to its predecessor, significantly improving the detection of elusive and aggressive cancers while minimizing false positive rates.
  • Furthermore, this version provides clinicians with the ability to include a previous examination in the ProFound Detection analysis of the current exam.
  • Dana Brown, President and CEO, iCAD, commented, “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,”
  • iCAD, Inc. (ICAD) shares experienced a range of $2.07 to $2.21 on a day volume of 329.40 thousand shares. The stock closed Monday’s regular trading session at $2.11, reflecting a 0.94 percent downfall.
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