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Somanetics Announces New FDA 510(K) Clearance
Date:4/16/2009

> SMTS) develops, manufactures and markets the INVOS(R) Cerebral/Somatic Oximeter which noninvasively provides accurate, real-time blood oxygen measurements in patients greater than 2.5 kilograms, and trend monitoring of this parameter for individuals of any weight. The INVOS System is the only commercially-available cerebral/somatic oximeter proven to improve outcomes in patients above 2.5 kilograms, and is the only cerebral/somatic oximeter system cleared for use on neonates less than 2.5 kg. Surgeons, anesthesiologists and other medical professionals can use data provided by the INVOS System, in conjunction with other available data, to identify oxygen imbalances in brain or other body tissue beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care. The INVOS System is the clinical reference standard in cerebral/somatic oximetry, with an 11-year market track record, more than 600 clinical references and implementation at more than 700 U.S. hospitals. Somanetics also is developing a technology that integrates data from bedside devices into a single system for enhanced patient assessment and decision making, data management and data storage. Somanetics supports its customers through a direct U.S. sales force and clinical education team. Covidien markets INVOS System products in Europe, Canada, the Middle East and South Africa and Edwards Lifesciences represents INVOS System products in Japan. For more information visit www.somanetics.com.


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