Zargis Medical Updates on FDA Submission
April 06 2004 - 11:50AM
PR Newswire (US)
Zargis Medical Updates on FDA Submission PRINCETON, N.J., April 6
/PRNewswire/ -- Zargis Medical Corp. today announced an update on
the status of its Premarket Notification, 510(k), application to
the Food and Drug Administrationfor clearance to market the Zargis
Acoustic Cardioscan (ZAC) System, filed in May 2003. The ZAC
System, Zargis' first clinical device, will initially be targeted
toward physicians to be used as part of general medical
examinations and physicals to detect murmurs. Zargis continues its
dialogue with the FDA and has submitted additional clinical data in
support of the application. The FDA does not provide timelines or
the likelihood of approvals. "Our most recent data is encouraging
and we remain very optimistic on gaining FDA clearance on our
510(k) submission," stated Dr. Shahram Hejazi, President and CEO of
Zargis. Published studies report a prevalence of heart murmurs
alone in up to 80% of children and the elderly, and approximately
20% in the adult population in the U.S. Given these statistics, an
aging population and budget pressures on healthcare, there is a
need for accurate auscultatory detection of heart murmurs. Zargis
Medical Corp. was formed in January 2001 when Siemens Corporate
Research Inc., a subsidiary of Siemens AG (NYSE:SI), and Speedus
Corp. (NASDAQ:SPDE) co-invested in Zargis to further develop and
commercially market an advanced acoustic technology for detecting
heart murmurs and other abnormalities. Based in Princeton, New
Jersey, Zargis is developing advanced diagnostic decision support
products and services for primary care physicians, cardiologists
and other healthcare professionals. For additional information
about Zargis Medical Corp., contact Shahram Hejazi, 609.734.6510, ,
or visit their website at http://www.zargis.com/. For additional
information on Speedus Corp., contact John Kallassy, 718.567.4358,
, or visit their website at http://www.speedus.com/. For additional
information on Siemens Corporate Research, visit their website at
http://www.scr.siemens.com/. Statements contained herein that are
not historical facts, including but not limited to statements about
the Company's product, corporate identity and focus, may be
forward-looking statements that are subject to a variety of risks
and uncertainties. There are a number of important factors that
could cause actual results to differ materially from those
expressed in any forward- looking statements made by the Company,
including, but not limited to, the continuing development of the
Company's sales, marketing and support efforts. DATASOURCE: Zargis
Medical Corp. CONTACT: Shahram Hejazi of Zargis Medical Corp.,
+1-609-734-6510 Web site: http://www.zargis.com/
http://www.speedus.com/ http://www.scr.siemens.com/
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