iCAD Announces FDA Clearance of ProFound AI™ for Digital Breast Tomosynthesis

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

NASHUA, N.H., Dec. 07, 2018 (GLOBE NEWSWIRE) -- (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 sets.”

ProFound 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 algorithm.

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 .

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 .

"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, 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”, “would”, “could”, “consider”, “project”, “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, including the 10-K for the year ended December 31, 2017, available on the Investors section of our website at  and on the SEC’s website at .

Contact:

Media Inquiries:

ARPR, on behalf of iCAD, Inc.

Paul Barren, (855) 300-8209

Investor Relations:

LifeSci Advisors

Jeremy Feffer, (212) 915-2568