Healthcare Industry News:  Edwards Lifesciences 

Devices Monitoring FDA

 News Release - May 24, 2010

Somanetics Receives 510(k) Clearance From the FDA to Expand Features on Its Vital Sync Monitor

Features Increase Interface with NICU and PICU Bedside Devices

TROY, Mich., May 24 (Healthcare Sales & Marketing Network) -- Somanetics Corporation (Nasdaq:SMTS ) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand features on its Vital Sync™ bedside monitor and research data aggregation system. The clearance allows for interface with a broader range of bedside devices, display of derived parameters of calculated clinical indices, and an automated events trigger to alert clinicians when patient parameters fall outside desired thresholds.

"We believe this new 510(k) supports our goal of providing monitoring technologies that help critical care clinicians simplify and manage the wealth of patient data involved in assessing and treating patients," said Bruce Barrett, Somanetics' president and chief executive officer. "Connectivity and display of additional vital patient parameters provides clinicians with 'dash-board' patient data to help clinicians' decision making and delivery of bedside care."

Somanetics' Vital Sync system provides the clinician with a view of patient data at the point of care to help medical professionals detect deteriorating patient condition early. The Vital Sync system allows the clinician to select specific patient data from an array of bedside devices and view the data on a single, time-synced display at the bedside. This focuses the clinician on relevant and interrelated patient data to enhance treatment decisions and improve patient care.

"Expanded compatibility with body cooling and perfusion equipment provides a more comprehensive device package for our neonatal and pediatric intensive care customers where hypothermic and ECMO treatment are used," adds Henry Szymanski, Somanetics' senior marketing manager. "In addition, the derived parameters and automated events features are expected to help clinicians transform individual patient metrics and events into more meaningful and actionable information."

About Somanetics

Somanetics Corporation (Nasdaq:SMTS ) develops, manufactures and markets the INVOS® Cerebral/Somatic Oximeter. The INVOS System is the only commercially-available cerebral/somatic oximeter with labeling for improved outcomes after surgery in patients above 2.5 kg. The INVOS System is the clinical reference standard in cerebral/somatic oximetry, with a 12-year market track record, more than 750 clinical references and implementation at approximately 800 U.S. hospitals. Somanetics also develops, manufactures and markets the Vital Sync™ System, a device 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.


Source: Somanetics

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