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iCAD's ProFound AI for digital breast tomosynthesis version 3.0 gets CE Mark approval

Press releases may be edited for formatting or style | June 17, 2021 Women's Health
NASHUA, N.H. – June 14, 2021 - iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI® Version 3.0 for Digital Breast Tomosynthesis (DBT) received CE Mark approval.

Compared to previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining an industry-leading high sensitivity level, and approximately 40% faster processing on the new PowerLook platform.[1]

"This CE Mark certification is another momentous achievement that positions iCAD in the vanguard of cancer detection and illustrates the Company's commitment to offering leading-edge solutions that continue to be unmatched by other technologies," said Michael Klein, Chairman and CEO of iCAD. "This regulatory milestone will provide the opportunity for our recently installed customers to upgrade to the latest version of the technology, while also expanding the potential to bring this solution to more markets – and thus more women – worldwide. This is not only consistent with our goal of establishing recurring revenue streams and predictable high margin revenues, it also stands to have a truly positive impact on patient care."

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The third generation of ProFound AI for DBT offers clinicians the ability to interpret the vast amount of data in DBT cases with greater precision and efficiency. A recent study involving ProFound AI Version 2.0 presented at two major breast imaging conferences earlier this year found that when radiologists factored in breast density and age, ProFound AI helped radiologists identify up to 58.6 percent of normal cases, with no false negatives.[2] ProFound AI Version 3.0 offers additional specificity and performance improvements over previous versions of the software, which stands to further improve these study results, and may also contribute to a reduction in the rate of false positives, without compromising cancer detection.

Built with the latest in deep-learning technology, ProFound AI for DBT Version 3.0 rapidly analyzes each tomosynthesis image, detecting malignant soft tissue densities and calcifications with unrivaled accuracy. Certainty of Finding and Case Scores are assigned to each detection and each case respectively. These are relative scores computed by the ProFound AI algorithm that represent the algorithm's confidence that a detection or case is malignant; this crucial information may help radiologists in clinical decision making.

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