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Hypertension News
Article Date: 21 Sep 2006 - 0:00am (PDT)
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Medwave Inc. (Nasdaq: MDWV), the innovator in
sensor-based, non-invasive blood pressure measuring
solutions, announced today that it has received
clearance by the U.S. Food and Drug Administration
(FDA) to market Fusion(TM), the first completely
sensor-based blood pressure with vital signs options
monitor.
Fusion is a non-invasive blood pressure measurement
device, built around Medwave's core sensor-based
blood pressure technology, which takes readings at
the wrist. Medwave's core technology has been the
subject of numerous independent clinical validation
studies, and results have shown that accuracy is
comparable to an invasive arterial catheter. Fusion
takes Medwave's core technology one step further by
incorporating proven, sensor-based pulse oxymetry by
Nellcor and thermometry by Kendall (both operating
companies of Tyco Healthcare Group LP), creating a
complete, non-invasive, vital signs solution.
"Fusion represents a turning point in the way health
providers care for their patients," said Medwave CEO
Tim O'Malley. "They now have a device to continually
monitor vital signs without invasive techniques.
That's something we never could have imagined 30
years ago."
The launch of Fusion(TM) follows on the heels of the
recent launch of Primo(R), a portable, handheld
blood pressure monitor that is currently in use at
hospitals and clinics nationwide. Medwave recently
announced distribution agreements with Tri-anim and
McKesson for Primo. Like Primo, Fusion's sensor-
based technology means that it is highly accurate,
and can monitor patients with 11-22cm wrist sizes.
"There is nothing like this on the market. Period,"
added O'Malley. "Our sensor-based technologies
represent an important step toward creating a
better, easier and more comfortable healthcare
experience for patients. No cuff, no catheter, no
kidding. That's us."
About Medwave
Medwave, Inc. develops, manufactures and distributes
sensor-based non- invasive blood pressure solutions.
Medwave's suite of products is designed for use in
hospitals, clinics, doctor's offices and almost
anywhere blood pressure monitoring occurs. Medwave
has the required technology clearances to market its
technology in the United States, Europe and Asia.
Medwave's technology is installed in more than 500
hospitals and clinics worldwide. Medwave trades on
the NASDAQ small cap market under the symbol MDWV.
For more information, visit
http://www.medwave.com.
Statements made in this release that are stated as
expectations, plans, anticipations, prospects or
future estimates or which otherwise look forward in
time are considered "forward-looking statements" and
involve a variety of risks and uncertainties, known
and unknown, which are likely to affect the actual
results. The following factors, among others, as
well as factors discussed in Medwave's filings with
the SEC, have affected and, in the future, could
affect Medwave's actual results: resistance to the
acceptance of new medical products, the market
acceptance of the Fusion(TM) system, the Primo(R)
system, the Vasotrac(R) system and other products of
Medwave, hospital budgeting cycles, the possibility
of adverse or negative results or commentary from
clinical researchers or other users or evaluators of
Medwave's products, Medwave's success in creating
effective distribution channels for its products,
Medwave's ability to scale up its manufacturing
process, and delays in product development or
enhancement or regulatory approval. Consequently, no
forward-looking statement can be guaranteed and
actual results may vary materially. Medwave(R),
Vasotrac(R), Legato(R), Primo(R), and Fusion(TM) are
trademarks of Medwave, Inc.
Medwave Inc.
http://www.medwave.com
