High-performance, cancer detection technology built on artificial
intelligence now available to healthcare facilities in the U.S.
New U.S. clearance based on clinical results demonstrating unprecedented
improvements in clinical performance and workflow efficiency
N.H., (December 7, 2018) – iCAD, Inc. (NASDAQ:
ICAD), a global medical technology leader providing innovative cancer
detection and therapy solutions, today announced clearance by the United States
Food and Drug Administration (FDA) for their latest, deep-learning, cancer
detection software solution for digital breast tomosynthesis (DBT), ProFound
AI™, clearing the technology for commercial sales and clinical use in the
United States. The powerful solution built on artificial intelligence (AI) is
now available to healthcare facilities in the U.S., providing access to the
most cutting-edge breast cancer detection software in the marketplace today.
“Obtaining FDA clearance for ProFound AI opens
a new and substantial addressable market for iCAD. This enables us to offer
clinicians globally an unrivaled cancer detection and workflow solution built
on the latest advances in deep-learning,” said Stacey Stevens, Executive Vice
President and Chief Strategy and Commercial Officer at iCAD. “Clinical reader
study results and comprehensive stand-alone testing have shown unprecedented improvements
in both clinical performance and reading efficiency. We are proud to introduce
revolutionary technology that will fundamentally transform breast cancer
detection and patient care.”
The FDA clearance is based on positive
clinical results from a large reader study completed earlier this year and
presented at this year’s Radiological Society of North America (RSNA) annual
meeting at McCormick Place in Chicago. The research was performed with 24
radiologists who read 260 tomosynthesis cases both with and without iCAD’s ProFound
AI solution. The findings show impressive results including increased cancer
detection rates, reduced false positive rates and patient recalls, and a
significant decrease in interpretation times.
“This technology shows tremendous promise in assisting radiologists in
detecting cancers, reducing recalls and increasing efficiency when reading
tomosynthesis studies,” said Emily Conant, MD, Professor and Chief, Division of
Breast Imaging, Vice Chair of Faculty Development, Department of Radiology at
the Hospital of the University of Pennsylvania. “Clinical data shows that when
tomosynthesis readers use the ProFound AI algorithm, case-level
sensitivity is improved by 8 percent on average and reading times are
significantly decreased. Radiologists with various levels of expertise may
benefit from this AI-driven technology when reading large tomosynthesis data
AI is a high-performance, deep-learning, cancer detection and workflow solution
for DBT delivering critical benefits to radiologists, their facilities, and
their patients through improvement of cancer detection rates by an
average of 8 percent and decreasing unnecessary patient recall rates by an
average of 7 percent. The new technology is trained to detect malignant
soft-tissue densities and calcifications. It also provides radiologists with
scoring information representing the likelihood that a detection or case is
malignant based on the large dataset of clinical images used to train the
In addition to improving clinical performance related to breast
cancer detection and false positive rates, study results showed that ProFound
AI can reduce radiologists’ reading time by more than 50 percent on average. An
increase in reading time has been a significant challenge for radiologists when
moving from 2D to 3D mammography.
The solution is currently available for use with leading DBT
systems in the U.S., Canada and Europe. For more information, visit www.icadmed.com.
About iCAD, Inc.
Headquartered in Nashua, NH, iCAD is a global
medical technology leader providing innovative cancer detection and therapy
solutions. For more information, visit www.icadmed.com.
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see the disclosure contained in our public filings with the Securities and
Exchange Commission, including the 10-K for the year ended December 31, 2017,
available on the Investors section of our website at http://www.icadmed.com and on the SEC’s
website at http://www.sec.gov.
ARPR, on behalf of iCAD, Inc.
Paul Barren, (855) 300-8209
Jeremy Feffer, (212) 915-2568