NASHUA, N.H., March 27, 2017 /PRNewswire/ -- iCAD (Nasdaq:
ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early
identification and treatment of cancer, today announced that PowerLook® Tomo Detection received Premarket Approval (PMA) from the
U.S. Food and Drug Administration (FDA). PowerLook Tomo Detection is a first-of-its-kind, concurrent-read computer aided
detection solution for digital breast 3D tomosynthesis and is the latest innovation available on the PowerLook® Breast Health
Solutions platform.
"As the use of 3D mammography continues to grow in the U.S. and abroad, iCAD remains committed to delivering innovative
solutions that help radiologists be more efficient and confident when reading tomosynthesis exams," said Ken Ferry, CEO of iCAD. "FDA approval of PowerLook Tomo Detection is a significant milestone for the Company
and we are positioned to rapidly advance our commercial plan for this innovative technology in the U.S. with the potential to
greatly improve clinical workflow and patient care in the years ahead."
2D digital mammography typically produces four images per exam while digital breast 3D tomosynthesis can produce hundreds of
images, significantly increasing exam interpretation time for radiologists. PowerLook Tomo Detection improves radiologists'
efficiency by automatically analyzing each tomosynthesis plane and identifying suspicious areas. The suspicious areas are
naturally blended onto a 2D synthetic image to provide radiologists with a single enhanced image that is used to more efficiently
navigate the large tomosynthesis data set.
"iCAD has taken a refreshing new approach to computer aided detection. This innovative workflow solution detects suspicious
areas on the tomosynthesis planes and that information is used to deliver an enhanced image that focuses the radiologist on the
specific areas that need further investigation," said Justin Boatsman, MD, Medical Director and diagnostic radiologist, Intrinsic
Imaging, LLC, who took part in the U.S. clinical study. "This not only helps reduce the reading time and improve the reading
experience for radiologists, but it can also provide radiologists with an added level of confidence."
In a U.S., clinical study conducted from October 2015 to January
2016, radiologists were able to significantly reduce reading time when reading 3D tomosynthesis exams with PowerLook Tomo
Detection. The study included 20 radiologists reading 240 tomosynthesis cases both with and without the PowerLook Tomo Detection
technology. Reading time was reduced by up to 37 percent with an average reduction of 29 percent when using PowerLook Tomo
Detection, with no statistically significant impact on sensitivity, specificity or recall rate. Another European clinical study
was completed with six radiologists reading 80 cases and showed similar results and was the basis for CE Mark of PowerLook Tomo
Detection in April 2016.
"This innovative software in PowerLook Tomo Detection is built on the latest deep learning technology to significantly improve
detection rates," said Jeff Hoffmeister, MD, Vice President and Medical Director at iCAD. "The use
of deep learning has enabled us to achieve a high detection rate of 92.3 percent." Deep learning is a branch of machine learning
that uses sophisticated algorithms that are trained to recognize the visual characteristics of a cancer by analyzing actual
patient images. The current version of the algorithm was trained using thousands of images.
PowerLook Tomo Detection, currently available on GE Healthcare digital breast tomosynthesis systems, also received CE Mark and
Health Canada approval in 2016, and is currently being used by multiple high volume breast imaging centers in Europe.
About iCAD, Inc.
iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and
treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer
aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers.
For more information, visit www.icadmed.com or www.xoftinc.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", "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, 2016, available on the Investors
section of our website at http://www.icadmed.com and on the SEC's website at
http://www.sec.gov.
Contact:
For iCAD investor relations:
The Ruth Group
Zack Kubow, 646-536-7030
www.theruthgroup.com
iCAD@theruthgroup.com
or
For iCAD media inquiries:
Berry & Company Public Relations, LLC
Lynn Granito, 212-253-8881
lgranito@berrypr.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/icad-receives-fda-approval-for-powerlook-tomo-detection-300429464.html
SOURCE iCAD