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BMEYE Announces FDA 510(K) Clearance for Nexfin(TM)


12/10/2007 10:40:20 AM

AMSTERDAM, December 10 /PRNewswire/ -- BMEYE(TM) announced today that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) to market Nexfin(TM), their newly developed line of safe, precise and easy to use hemodynamic monitors. The Nexfin(TM) monitors provide precise and easy to use continuous non-invasive blood pressure and cardiac output monitoring. BMEYE(TM) received CE market approval earlier this year.

"BMEYE(TM) was established to develop and market innovative technology that will transform the practice of medicine in hemodynamic patient monitoring. The product launch of Nexfin(TM) in Europe earlier this year has been very successful. We are eager to now launch Nexfin(TM) in the United States. Cardiologists and any clinician who needs to measure continuous non-invasive blood pressure and cardiac output easily and precisely will benefit," said Bill Bednarski, CEO of BMEYE(TM). "The Nexfin(TM) is cost effective and will significantly improve patient care."

BMEYE(TM) develops and markets innovative medical technology with broad applications in a variety of clinical settings. The focus of BMEYE(TM) is on precise and easy to use non-invasive hemodynamic monitoring. The Nexfin(TM) family of monitors use an easy to apply finger sensor to produce precise continuous non-invasive blood pressure and cardiac output data displayed on an intuitive touchscreen.

Patents pending. For more information please check our web site at http://www.bmeye.com.

CONTACT: Contact Information: Bill Bednarski, CEO BMEYE, Academic Medical
Center, Suite K2-245, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands,
Phone: +31-(0)20-566-7720, Email: bill.bednarski@bmeye.com; Center for
Emerging Technologies, 4041 Forest Park Avenue, St. Louis, Missouri, 63108,
USA, Phone: +1-925-270-0741


Read at BioSpace.com

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