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iCAD Submits Lung Cancer Detection Support Product to the FDA
- Distribution Agreements in Place with TeraRecon and Viatronix -
NASHUA, N.H., April 18 /PRNewswire-FirstCall/ -- iCAD(R), Inc. (NASDAQ: ICAD),
an industry-leading provider of Computer-Aided Detection (CAD) solutions for
the early identification of cancer, today announced that it recently submitted
its Premarket Notification 510(k) Application with the U.S. Food and Drug
Administration (FDA) seeking clearance to market and sell its first product for
use in the detection of lung cancer.
As an image processing application intended to support computed tomography (CT)
review workstation software, iCAD's lung cancer detection product has been
designed to make the medical review of lungs in CT scans more efficient and
productive. The solution identifies roughly-spherical objects in the lung that
meet radiologist-specified size, shape and brightness criteria, enabling
healthcare professionals to improve workflow by spending more time reviewing
potential areas of lung cancer concern.
"Our recent lung cancer detection support product FDA submission marks an
important milestone for iCAD," said Scott Parr, President and CEO of iCAD, Inc.
"We look forward to helping the medical community improve CT Lung workflow
productivity by using our imaging expertise and advanced technology to make
medical services more effective, more accessible and more affordable for
patients worldwide."
Distribution agreements for iCAD's lung cancer detection products are already
in place with TeraRecon, Inc. and Viatronix, Inc., both of which are expected
to commence marketing of the offering as soon as FDA approval is received and
product development and release plans are finalized.
iCAD's submission was made to Underwriters Laboratories (UL), as a
representative of the FDA under the FDA Accredited Persons Program, created by
the FDA Modernization Act of 1997 (FDAMA). The purpose of the program is to
improve the efficiency and timeliness of FDA's 510(k) process, the process by
which most medical devices receive marketing clearance in the United States.
Under the program, FDA has accredited third parties that are authorized to
conduct the primary review.
About iCAD, Inc.
iCAD, Inc. is an industry-leading provider of Computer-Aided Detection (CAD)
solutions that enable healthcare professionals to identify cancer and other
life-threatening conditions earlier by making medical services more effective,
more accessible and more affordable for patients worldwide. Recipient of Frost
& Sullivan's Growth Strategy Leadership award and repeatedly recognized as
offering "The Winning Combination" of Price and Performance by MD Buyline, iCAD
offers a comprehensive range of high-performance, upgradeable CAD systems for
the high, mid and low volume mammography markets. As the most frequently
selected CAD solution for film-based and digital breast screening, iCAD is
entrusted with the task of early cancer detection by almost one thousand
women's healthcare centers worldwide. For more information, call +1 866 iCADnow
or visit http://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
risks of uncertainty of patent protection, the impact of supply and
manufacturing constraints or difficulties, product market acceptance, possible
technological obsolescence, increased competition, customer concentration and
other risks detailed in the Company's other filings with the Securities and
Exchange Commission. The words "believe," "demonstrate," "intend," "expect,"
"estimate," "anticipate," "likely," 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.
DATASOURCE: iCAD, Inc.
CONTACT: For more information on iCAD, Inc., contact Kevin McGrath of
Cameron Associates at +1-212-245-4577 or via email at
Web site: http://www.icadmed.com/