Zargis Medical Receives FDA Clearance:
September 14 2004 - 1:04PM
PR Newswire (US)
Zargis Medical Receives FDA Clearance: Energy Display and Timing
Annotation Added to Cardioscan PRINCETON, N.J., Sept. 14
/PRNewswire/ -- Zargis Medical Corp., a majority-owned subsidiary
of Speedus Corp. (NASDAQ:SPDE), announced today it has received
U.S. Food and Drug Administration (FDA) clearance to include a
graphical display of the median energy level, timing, and duration
of suspected heart murmurs during specific segments of the
diastolic and systolic intervals of heartbeats recorded through the
Zargis Acoustic Cardioscan (Cardioscan(TM)). The new displays will
better represent the distribution of acoustic energy of the heart
for each recorded location and help physicians characterize
suspected murmurs in terms of onset, duration and loudness. This
clearance represents one of the planned development milestones
required for a full commercial rollout of Cardioscan. Zargis will
be demonstrating Cardioscan, with energy display and timing
annotation, at the American Heart Association Scientific Sessions
in New Orleans on November 7th - 10th. "We have developed the most
comprehensive and advanced heart sound analysis and interpretation
algorithms in the world. This FDA clearance represents another
first for Zargis and demonstrates our commitment to extending the
clinical usefulness of cardiac auscultation (listening to heart
sounds). Because auscultation is a difficult clinical skill, and
with fewer than 28% of internal medicine programs in the United
States offering any structured teaching in cardiac auscultation, we
see a need for continued innovations in the field of cardiac sound
diagnostics," said John Kallassy, Managing Director of Zargis
Medical. The acoustic signal generated by the heart contains
significant energy at frequencies below the threshold of human
hearing. The decline in auscultation skills has also led to a
possible over-reliance on costly echocardiography for the diagnosis
of heart murmurs. Consequently, a large percentage of
echocardiograph studies are performed on patients with innocent
heart murmurs. About Cardioscan Cardioscan is the first and only
computer-aided medical device to support physicians in analyzing
heart sounds for the identification of suspected murmurs, a
potential sign of heart disease. Cardioscan is easy to use,
non-invasive, portable, and takes just minutes to perform.
Developed by biomedical scientists from Siemens and Zargis over the
past seven years, Cardioscan implements voice-guided protocol and
graphical user interface while maintaining an efficient physician
workflow. The system provides a summary of findings in terms that
are readily understood by physicians with more quantitative
auscultatory information than is possible through listening alone.
Thus, Cardioscan enhances auscultation which has been universally
employed through a stethoscope for nearly two hundred years. About
Zargis Medical Corp. 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 abnormalities identified through analysis
of heart sounds. 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 on Speedus
Corp. or Zargis Medical, contact John Kallassy, 718.567.4358, , or
visit their websites at http://www.speedus.com/ and
http://www.zargis.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: John Kallassy, +1-718-567-4358, Web site:
http://www.speedus.com/ http://www.zargis.com/
http://www.scr.siemens.com/
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