VIASYS NeuroCare Inc. Receives 510(K) Clearance for SONARA and SONARA/tek Digital Transcranial Doppler Systems.CONSHOHOCKEN, Pa. -- VIASYS Healthcare Inc. (NYSE NYSE See: New York Stock Exchange :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 TCD Trinity College Dublin TCD Chad (ISO Country code) TCD Transcranial Doppler TCD Thermal Conductivity Detector TCD Traffic Control Device TCD Tropical Conservation and Development ) systems. VIASYS will introduce both TCD systems on November 15 at the MEDICA medica (māˑ·dē·k Healthcare meeting, the world's largest healthcare conference, which is held annually in DE-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 AVEA American Veterinary Exhibitors Association (R), BEAR(R), BIRD(R), CORFLO CORFLO CORridor FLOw (R), CORPAK(R), CORTRAK(R), EME n. 1. An uncle. (R), GRASON-STADLER(R), JAEGER(TM), LYRA(R), MEDELEC(R), MICROGAS(R), NAVIGATOR(R), NICOLET(R), NicoletOne(TM), PULMONETIC(TM), SENSORMEDICS(R), TECA TECA Technology for Agriculture (FAO initiative) TECA ThermoElectric Cooling America Corporation TECA Tennessee Electric Cooperative Association TECA Texas Education Consumers Association TECA Tower En-Route Control Area (R), TECOMET(TM), VELA vela plural of velum. (R) and VMAX VMAX Maximum Voltage VMAX Velocity Maximum VMAX Basic Clean Aircraft Maximum CAS (aviation) VMAX Maximum Volume to be Remediated VMAX Maximum Velocity (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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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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