First and Only FDA-Cleared Artificial Intelligence
Solution Supporting Breast Cancer Detection in 3D Tomosynthesis Recognized by
Annual Awards Program


N.H – September 4, 2019 – iCAD, Inc.
(“iCAD”) (NASDAQ: ICAD), a global medical technology leader providing
innovative cancer detection and therapy solutions, today announced MedTechBreakthrough, an independent organization that recognizes
the top companies and solutions in the global health and medical technology
market, selected the Company’s ProFound AI™ platform as the winner of its “Best
New Radiology Solution” award in the 2019 MedTech Breakthrough Awards program.


ProFound AI™ for Digital Breast Tomosynthesis
(DBT) is the first and only FDA-cleared artificial intelligence (AI) solution
that supports breast cancer detection in DBT, or 3D mammography. The technology
is intended to be used concurrently by radiologists reading DBT exams and uses
a cutting-edge algorithm developed with the latest in deep-learning.


Trained to detect malignant soft-tissue
densities and calcifications, ProFound AI aids radiologists in breast cancer
detection and is clinically proven to improve cancer detection rates, reduce
false positives and unnecessary patient recalls, and decrease reading times for
radiologists. The software rapidly and accurately analyzes
each DBT image and provides radiologists with key information, such as unique Certainty
of Finding and Case Scores, which assist radiologists in making clinical
decisions and prioritizing caseloads.


intelligence is revolutionizing healthcare by improving operational efficiency,
clinician confidence, and patient outcomes, and iCAD is committed to remaining
on the forefront of this movement. We are honored to accept this award, which further
validates ProFound AI as a leading solution that offers benefits to both radiologists
and their patients,” according to Stacey Stevens, president of iCAD. “ProFound
AI for DBT is clinically proven to improve sensitivity by 8 percent, reduce
unnecessary patient recall rates by 7.2 percent, and slash reading time for
radiologists by over 50 percent.”1


The mission of the MedTech Breakthrough Awards
is to honor excellence and recognize the innovation, hard work and success in a
range of health and medical technology categories, including robotics, clinical
administration, telehealth, patient engagement, electronic health records
(EHR), mHealth, and medical devices. This year’s program attracted over 3,500
nominations from more than 15 different countries throughout the world.


“iCAD is a previous MedTech Breakthrough Award
winner, and we are delighted to see the Company continue to innovate. ProFound
AI is a revolutionary technology built on the latest deep-learning and
artificial intelligence technology that assists radiologists and addresses the
challenges of reading breast tomosynthesis cases,” said James Johnson, managing
director, MedTech Breakthrough. “We extend a hearty congratulations to the
entire iCAD team on their innovative spirit and ability to execute on
incorporating sophisticated AI technology in a platform that delivers
incredibly real-world benefits.”


ProFound AI for DBT runs on the
industry-leading PowerLook platform with NVIDIA Graphical Processing Units
(GPU). PowerLook is a flexible and reliable DICOM platform that easily
integrates with image modalities, mammography review workstations, PACS, and
image storage systems. Leveraging the latest in GPU technology, the algorithm
can rapidly process a 4-view tomosynthesis case, ensuring results are available
to radiologists in the most efficient manner. Currently, ProFound AI for DBT is
available for use with leading DBT systems in Europe, Canada and the United
States and its adoption continues to grow globally.


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


iCAD, Inc.

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


About MedTech
Part of Tech Breakthrough, a leading market
intelligence and recognition platform for global technology innovation and
leadership, the MedTech Breakthrough Awards program is an independent
program devoted to honoring excellence in medical and health related technology
companies, products, services and people. The MedTech Breakthrough Awards
provide a platform for public recognition around the achievements of
breakthrough health and medical companies and products in categories that
include Patient Engagement, mHealth, Health & Fitness, Clinical
Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and
more. For more information visit

“Safe Harbor” Statement under the
Private Securities Litigation Reform Act of 1995

Certain statements contained in this News
Release constitute “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Such forward-looking
statements involve a number of known and unknown risks, uncertainties and other
factors which may cause the actual results, performance or achievements of the
Company to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. Such
factors include, but are not limited, to the Company’s ability to defend itself
in litigation matters, to achieve business and strategic objectives, the risks
of uncertainty of patent protection, the impact of supply and manufacturing
constraints or difficulties, uncertainty of future sales levels, protection of
patents and other proprietary rights, the impact of supply and manufacturing
constraints or difficulties, product market acceptance, possible technological
obsolescence of products, increased competition, litigation and/or government
regulation, changes in Medicare or other reimbursement policies, risks relating
to our existing and future debt obligations, competitive factors, the effects
of a decline in the economy or markets served by the Company; and other risks detailed
in the Company’s filings with the Securities and Exchange Commission. The words
“believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,”
“anticipate,” “likely,” “seek,” and similar expressions identify
forward-looking statements. Readers are cautioned not to place undue reliance
on those forward-looking statements, which speak only as of the date the
statement was made. The Company is under no obligation to provide any updates
to any information contained in this release. For additional disclosure
regarding these and other risks faced by iCAD, please see the disclosure
contained in our public filings with the Securities and Exchange Commission,
available on the Investors section of our website at and
on the SEC’s website at


Media Inquiries:

Jessica Burns, iCAD



Investor Relations:

Jeremy Feffer, LifeSci Advisors

+ 1-212-915-2568