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iCAD’s ProFound AI™ for 2D Mammography Receives CE Mark Approval

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Deep-learning, artificial intelligence technology assists radiologists in detecting breast cancer

NASHUA, N.H., July 11, 2019 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced its advanced artificial intelligence technology and workflow solution, ProFound AI™ for 2D Mammography, received CE Mark approval. The technology is the latest addition to iCAD’s deep-learning ProFound AI™ platform, joining ProFound AI™ for Digital Breast Tomosynthesis (DBT), which was CE Marked in March 2018, FDA-cleared in December 2018, and Health Canada licensed in July 2018. The technology was developed to support the detection of breast cancer through the identification of soft tissue densities and calcifications.

“Europe contains 9% of the world’s population but has more than 23% of the global cancer burden, with breast cancer being the most common cancer among European women,”1,2 stated Stacey Stevens, President of iCAD. “This CE Mark further validates our ProFound AI platform as a world-class artificial intelligence solution that offers benefits to both radiologists and screening-aged women in detecting breast cancer. iCAD is committed to improving patient care worldwide and we are pleased to offer this powerful technology to a growing number of hospitals, imaging centers and women across Europe.”

ProFound AI for 2D Mammography is a high-functioning, deep-learning algorithm that analyzes each mammography image and provides critical insight into each individual case, such as highlighting the most suspicious areas and assigning unique Certainty of Finding and Case Scores, which can assist radiologists in making clinical decisions and prioritizing caseloads. The ProFound AI platform is built upon the latest in deep-learning artificial intelligence and allows for continuously improved performance via ongoing software updates.

“ProFound AI for 2D Mammography has the potential to assist radiologists in their interpretation of 2D mammography images, as we have seen with ProFound AI for DBT,” according to Axel Gräwingholt, MD, Radiologie am Theater, in Paderborn, Germany. “As breast cancer rates continue to rise, it is imperative for radiologists to find cancers sooner, when they may be more easily treated, with fewer callbacks and false positives, which can be inconvenient and stressful for patients.”

For more information, visit www.icadmed.com.

References:

  1. GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. https://www.uicc.org/news/new-global-cancer-data-globocan-2018. Accessed July 2019.
  2. United Nations, Population division. World Population Prospects, the 2019 revision. https://www.un.org/development/desa/publications/world-population-prospects-2019-highlights.html. Accessed July 2019.

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.

"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 http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contacts:

Media Inquiries:
Jessica Burns, iCAD  
+1-201-423-4492
jburns@icadmed.com

Investor Relations:
Jeremy Feffer, LifeSci Advisors
+ 1-212-915-2568
jeremy@lifesciadvisors.com

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