generation AI solution offers significant improvement in algorithm specificity
performance and faster processing compared to previous versions of the software
Deep learning technology builds upon iCAD’s
established leadership in mammography AI
NASHUA, N.H. –
March 15, 2021 – iCAD, Inc. (NASDAQ: ICAD), a
global medical technology leader providing innovative cancer detection and
therapy solutions, today announced that ProFound AI® Version 3.0 for
Digital Breast Tomosynthesis (DBT) was cleared by the U.S. Food and Drug Administration
(FDA). Compared to previous versions of the software, the ProFound AI 3.0
algorithm offers up to a 10% improvement in specificity performance and up to
1% improvement in sensitivity. ProFound AI Version 3.0 also offers up to 40% faster
processing on the new PowerLook platform.
“The FDA Clearance of ProFound AI Version 3.0 is yet
another milestone that positions iCAD and our technology as vanguards in the
cancer detection realm. Our third generation AI solution for DBT may afford
physicians the ability to interpret an increasing amount of data in DBT cases
and analyze each image to detect malignant lesions more efficiently and with
even greater precision,” said Michael Klein, Chairman and CEO of iCAD. “Improvements
in specificity, which correlates with reductions in false positives, typically
come at the expense of sensitivity and cancer detection scores. To increase
sensitivity while simultaneously improving specificity is a huge performance
ProFound AI for DBT is a high-performance, deep-learning,
workflow solution trained to detect malignant soft tissue densities and
calcifications. It became the first 3D tomosynthesis software using artificial
intelligence (AI) to be FDA cleared in December 2018.
Built with the latest in deep-learning technology,
ProFound AI for DBT rapidly analyzes each tomosynthesis image, detecting
malignant soft tissue densities. Certainty
of Finding and Case Scores are relative scores computed by the ProFound AI
algorithm and represent its confidence that a detection or case is malignant.
The Certainty of Finding scores help radiologists by aiding in clinical
decision making. Case Scores, which are assigned to each case by the algorithm,
help clinicians to gain a sense of case complexity, which may be useful for
prioritizing the reading work list.
ProFound AI Version 3.0 was
developed using over five million images from 30,000 cases, including almost
8,000 biopsy-proven cancers, and validated on approximately one million images
from 3,500 cases that included 1,200 biopsy-proven cancers.
“Late last year we made the decision to go
enterprise-wide with ProFound AI,” said Alexander SardiÃ±a, MD, Chief Medical
Officer for Solis Mammography. “From a patient perspective, improved
specificity and sensitivity means that we can minimize the anxiety caused by false
positives and recalls, without compromising cancer detection rates. This is a
significant achievement. We’re excited to put this technology to work – on
behalf of our patients – across our national network of facilities.”
In a reader
study published in Radiology,
ProFound AI for DBT Version 2.0 was shown to offer clinically proven
time-savings benefits to radiologists, reducing reading time by 52.7 percent,
improving radiologist sensitivity by 8 percent, and reducing false positives
and unnecessary patient recall rates by 7.2 percent.
Health Solutions suite also includes ProFound AI for 2D Mammography, ProFound
AI Risk, the world’s first and only clinical decision support tool that
provides an accurate two-year, breast cancer risk estimation that is truly
personalized for each woman, based only on a screening mammogram,
and software to evaluate breast density.
About iCAD, Inc.
statements contained in this News Release constitute “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements about the benefits of the Company’s agreement
with Solis and future prospects for the Company’s technology platforms and
products. 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 achieve business and strategic objectives, the willingness
of patients to undergo mammography screening in light of risks of potential
exposure to Covid-19, whether mammography screening will be treated as an
essential procedure, whether ProFound AI will improve reading
efficiency, improve specificity and sensitivity, reduce false
positives and otherwise prove to be more beneficial for patients and
clinicians, the impact of supply and manufacturing constraints or
difficulties on our ability to fulfill our orders, uncertainty of future sales
levels, to defend itself in litigation matters, protection of patents and other
proprietary rights, product market acceptance, possible technological
obsolescence of products, increased competition, 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.
 *iCAD data on file. Standalone
performance varies by vendor. FDA Cleared.
 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 https://pubs.rsna.org/doi/10.1148/ryai.2019180096
 Eriksson M, Czene K, Strand F, et al.
Identification of Women at High Risk of Breast Cancer Who Need Supplemental
Screening. [published online ahead of print September 8, 2020]. Radiology.
Accessed via https://doi.org/10.1148/radiol.2020201620