VIASYS NeuroCare Inc. Receives 510(K) Clearance for SONARA and SONARA/tek Digital Transcranial Doppler Systems
15 November 2006 - 9:13AM
Business Wire
VIASYS Healthcare Inc. (NYSE:VAS) announced today that it has
received 510(K) clearance from the U.S. Food and Drug
Administration for SONARA� and SONARA/tek� digital Transcranial
Doppler (TCD) systems. VIASYS will introduce both TCD systems on
November 15 at the MEDICA Healthcare meeting, the world�s largest
healthcare conference, which is held annually in D�sseldorf,
Germany. TCD is a non-invasive method of measuring blood flow
velocities in the arteries of the brain using ultrasound Doppler
technology. SONARA and SONARA/tek systems were developed with a new
digital data acquisition approach that provides much higher
resolution data than has ever been available. For clinicians, this
translates directly to increased productivity due to improved
signal acquisition. "The SONARA and SONARA/tek systems provide
advanced TCD tools for diagnosis, monitoring and treatment of
cerebrovascular disease, especially stroke," said Lori Cross, Group
President of VIASYS NeuroCare. "These systems represent a
significant addition of neurovascular technology to the NeuroCare
portfolio." The SONARA product is a fully integrated system, while
the SONARA/tek is a Doppler module that allows connectivity to a PC
or our current TCD products for an affordable choice without
compromising high-end features. The product line represents the
best in modern TCD technology with exclusive features such as: an
intuitive touch screen user interface superior signal acquisition
250-gate high resolution M-Mode flexible display formats including
a velocity profile interactive summary screens for physician review
that allow playback of up to 120 seconds of each saved Doppler
waveform in diagnostic mode continuous soundtrak replay of
monitoring exams exam to exam trending statistics package With
additional languages and these differentiated features, we believe
SONARA and SONARA/tek products should help accelerate the adoption
of TCD technology by new users to serve new markets and clinical
settings. ABOUT VIASYS HEALTHCARE INC. VIASYS Healthcare Inc. is a
global, research-based medical technology company focused on
respiratory, neurology, medical disposable and orthopedic products.
VIASYS products are marketed under well-recognized trademarks
including, among others, AVEA(R), BEAR(R), BIRD(R), CORFLO(R),
CORPAK(R), CORTRAK(R), EME(R), GRASON-STADLER(R), JAEGER(TM),
LYRA(R), MEDELEC(R), MICROGAS(R), NAVIGATOR(R), NICOLET(R),
NicoletOne(TM), PULMONETIC(TM), SENSORMEDICS(R), TECA(R),
TECOMET(TM), VELA(R) and VMAX(R). VIASYS is headquartered in
Conshohocken, PA, and its businesses are conducted through its
Respiratory Care, NeuroCare, MedSystems and Orthopedics business
units. More information can be found at
http://www.viasyshealthcare.com. This news release includes
forward-looking statements within the meaning of the "Safe Harbor"
provisions of Private Securities Litigation Reform Act of 1995
regarding the neurovascular marketplace and product portfolio and
the expectations regarding the acceleration of the adoption of TCD
technology. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties,
including important factors that could delay, divert, or change the
expectations for VIASYS' products and could cause actual outcomes
and results to differ materially from current expectations. These
factors include, among other things, market factors (including the
growth of the vascular diagnostics market), market acceptance and
adoption of TCD technology, internal research and development
initiatives, partnered research and development initiatives,
competitive product development, marketing initiatives,
governmental regulations and legislation, and patent positions and
litigation. For further details and a discussion other risks and
uncertainties that may change VIASYS' expectations, please see
VIASYS' annual report on Form 10-K for the year ended December 31,
2005, which is on file with the Securities and Exchange Commission.
VIASYS undertakes no obligation to publicly update this
forward-looking statement, whether as a result of new information,
future events, or otherwise. VIASYS Healthcare Inc. (NYSE:VAS)
announced today that it has received 510(K) clearance from the U.S.
Food and Drug Administration for SONARA(TM) and SONARA/tek(TM)
digital Transcranial Doppler (TCD) systems. VIASYS will introduce
both TCD systems on November 15 at the MEDICA Healthcare meeting,
the world's largest healthcare conference, which is held annually
in Dusseldorf, Germany. TCD is a non-invasive method of measuring
blood flow velocities in the arteries of the brain using ultrasound
Doppler technology. SONARA and SONARA/tek systems were developed
with a new digital data acquisition approach that provides much
higher resolution data than has ever been available. For
clinicians, this translates directly to increased productivity due
to improved signal acquisition. "The SONARA and SONARA/tek systems
provide advanced TCD tools for diagnosis, monitoring and treatment
of cerebrovascular disease, especially stroke," said Lori Cross,
Group President of VIASYS NeuroCare. "These systems represent a
significant addition of neurovascular technology to the NeuroCare
portfolio." The SONARA product is a fully integrated system, while
the SONARA/tek is a Doppler module that allows connectivity to a PC
or our current TCD products for an affordable choice without
compromising high-end features. The product line represents the
best in modern TCD technology with exclusive features such as: --
an intuitive touch screen user interface -- superior signal
acquisition -- 250-gate high resolution M-Mode -- flexible display
formats including a velocity profile -- interactive summary screens
for physician review that allow playback of up to 120 seconds of
each saved Doppler waveform in diagnostic mode -- continuous
soundtrak replay of monitoring exams -- exam to exam trending --
statistics package With additional languages and these
differentiated features, we believe SONARA and SONARA/tek products
should help accelerate the adoption of TCD technology by new users
to serve new markets and clinical settings. ABOUT VIASYS HEALTHCARE
INC. VIASYS Healthcare Inc. is a global, research-based medical
technology company focused on respiratory, neurology, medical
disposable and orthopedic products. VIASYS products are marketed
under well-recognized trademarks including, among others, AVEA(R),
BEAR(R), BIRD(R), CORFLO(R), CORPAK(R), CORTRAK(R), EME(R),
GRASON-STADLER(R), JAEGER(TM), LYRA(R), MEDELEC(R), MICROGAS(R),
NAVIGATOR(R), NICOLET(R), NicoletOne(TM), PULMONETIC(TM),
SENSORMEDICS(R), TECA(R), TECOMET(TM), VELA(R) and VMAX(R). VIASYS
is headquartered in Conshohocken, PA, and its businesses are
conducted through its Respiratory Care, NeuroCare, MedSystems and
Orthopedics business units. More information can be found at
http://www.viasyshealthcare.com. This news release includes
forward-looking statements within the meaning of the "Safe Harbor"
provisions of Private Securities Litigation Reform Act of 1995
regarding the neurovascular marketplace and product portfolio and
the expectations regarding the acceleration of the adoption of TCD
technology. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties,
including important factors that could delay, divert, or change the
expectations for VIASYS' products and could cause actual outcomes
and results to differ materially from current expectations. These
factors include, among other things, market factors (including the
growth of the vascular diagnostics market), market acceptance and
adoption of TCD technology, internal research and development
initiatives, partnered research and development initiatives,
competitive product development, marketing initiatives,
governmental regulations and legislation, and patent positions and
litigation. For further details and a discussion other risks and
uncertainties that may change VIASYS' expectations, please see
VIASYS' annual report on Form 10-K for the year ended December 31,
2005, which is on file with the Securities and Exchange Commission.
VIASYS undertakes no obligation to publicly update this
forward-looking statement, whether as a result of new information,
future events, or otherwise.
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