and Only FDA-Cleared Digital Breast Tomosynthesis Software with Artificial
Intelligence Clinically Proven to Enhance Breast Cancer Screening, Reduce False
Positives and Slash Reading Time for Radiologists in Half


Nashua, N.H. – September 10, 2019 – iCAD, Inc. (NASDAQ:
ICAD), a global medical technology leader providing innovative cancer
detection and therapy solutions, today announced the results of its reader
study for ProFound AI™ for Digital Breast Tomosynthesis (DBT) were published in
the peer-reviewed journal, Radiology:
Artificial Intelligence. ProFound AI for DBT is the first and only FDA-cleared 3D tomosynthesis workflow solution using
artificial intelligence (AI) to aid in breast cancer detection. The study
showed the concurrent use of ProFound AI increased sensitivity by 8 percent,
reduced false positives and unnecessary recalls by 7 percent, and slashed
reading time for radiologists by 52.7 percent.1


“The publication of our reader study results in such
a renowned peer-reviewed journal is a significant milestone that further validates
ProFound AI as a world-class, deep-learning workflow solution that offers real-world
benefits to radiologists and patients alike,” said Michael Klein, Chairman and
CEO of iCAD. “This endorsement of our research substantiates ProFound AI as the
leading artificial intelligence breast cancer detection technology that
clinicians to read DBT images in less time and find cancers earlier, when they
may be more easily treated.”


ProFound AI is a high-performing workflow
solution that assists radiologists by detecting malignant soft-tissue densities
and calcifications. The software
rapidly and accurately analyzes each image, or
slice, and provides radiologists with crucial
information, such as Certainty of Finding lesion and Case Scores
, which
can assist in clinical decision-making and prioritizing caseloads. Featuring the latest in deep-learning intelligence, the technology
allows for continuously improved performance via ongoing software updates.


“While screening with DBT has been shown to
increase cancer detection while also decreasing false positive recalls, the
exponentially larger number of images in a DBT study compared to 2D screening
studies almost doubles the reading time for radiologists,” said principal
investigator and lead author Emily F. Conant, M.D., professor and chief of
breast imaging from the Department of Radiology at the Perelman School of
Medicine at the University of Pennsylvania in Philadelphia. “This reader study
shows that the concurrent use of AI when reading DBT screening studies
optimizes efficiency while also improving accuracy.”


The reader study examined the performance of 24 radiologists, including 13
breast subspecialists, reading an enriched set of 260 DBT cases, both with and
without ProFound AI. The study found ProFound AI increased radiologist
performance, measured by mean area under the
receiver operating
characteristic curve (AUC), from 0.795 to 0.852. ProFound AI also increased sensitivity
from 77.0 percent to 85.0 percent, increased specificity from 62.7 percent to
69.6 percent, and decreased the recall rate for noncancers from 38.0 percent to
30.9 percent. Reading time for radiologists decreased from 64.1 seconds to 30.4
seconds with ProFound AI.


ProFound AI for DBT was FDA cleared, CE marked, and Health Canada
licensed in 2018. For more information, visit




1.)Conant, E. et al. (2019). Improving
Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for
Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4).
Accessed via


this study

data were retrospectively collected in compliance with the Health Insurance
Portability and Accountability Act, with institutional review board approval
and waiver of informed consent. The study was financially supported by iCAD and
performed by Intrinsic Imaging.


About iCAD, Inc.

Headquartered in Nashua, N.H., iCAD is a global medical technology
leader providing innovative cancer detection and therapy solutions. For more
information, visit


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Litigation Reform Act of 1995

Certain statements contained in this News Release constitute
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Litigation Reform Act of 1995. Such forward-looking statements involve a number
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Media Inquiries:

Jessica Burns, iCAD  

(201) 423-4492


Investor Relations:

Feffer, LifeSci Advisors, Inc.