BMEYE Receives FDA Clearance to Launch ccNexfin, the First Totally Noninvasive Cardiovascular Monitor With BP, CO, and Masimo Rainbow SET(R) Technology in the United States

By Bmeye B.v., PRNE
Wednesday, November 17, 2010

ccNexfin has an Unique Offering With Totally Noninvasive Beat-to-Beat Blood Pressure (BP), Cardiac Output (CO), and Masimo's Breakthrough Noninvasive Hemoglobin and Oxygen Saturation Measurements

AMSTERDAM, November 18, 2010 - BMEYE B.V., the innovators of combined totally noninvasive, beat-to-beat
blood pressure and cardiac output monitoring announces FDA clearance and the
United States
launch of the BMEYE ccNexfin-the first totally noninvasive
cardiovascular monitor with blood pressure, cardiac output, and Masimo
rainbow(R) SET Pulse CO-Oximetry(TM) measurements. The combination of two
innovative noninvasive technologies-BMEYE for cardiovascular monitoring and
Masimo rainbow SET for noninvasive and continuous hemoglobin and oxygen
saturation monitoring-provides real-time, beat-to-beat measurements of
cardiac, circulatory, and pulmonary parameters, which may enable clinicians
to detect impending cardiovascular crisis before organ injury ensues in
critical care.

Hemodynamic monitoring has traditionally relied upon invasive, costly,
intermittent, or unreliable methods to assist clinicians in maintaining
adequate oxygen delivery and tissue perfusion to prevent hypoxia and its
irreversible damage. However, the ccNexfin with Masimo rainbow SET offers a
totally noninvasive method of providing some of the most advanced
cardiovascular and hemodynamic monitoring capabilities available today. It
utilizes a BMEYE finger cuff to capture and continuously measure beat-to-beat
blood pressure (sys/dia), mean arterial pressure (MAP), cardiac output (CO),
stroke volume (SV), systemic vascular resistance (SVR), and derivative of
pressure (dP/dt), and a Masimo finger sensor to noninvasively and
continuously measure hemoglobin (SpHb(R)), oxygen saturation (SpO2), oxygen
content (SpOC(TM)), and perfusion index (PI). This detailed data allows
clinicians to predict and proactively address the early signs of hemodynamic
instability during critical situations rather than reacting to late
indicators and their effects.

"ccNexfin has been very well received in the critical care market since
its European launch in January this year. We are very excited to offer this
unique totally noninvasive solution to U.S. physicians" stated Rob de Ree,
CEO of BMEYE. "The combination of beat-to-beat blood pressure with cardiac
output along with Masimo rainbow SET Pulse CO-Oximetry capabilities has the
potential to provide earlier diagnosis and early goal-directed therapies in
anesthesia and emergency care to improve patient care while reducing costs."

Masimo Founder and CEO, Joe Kiani, stated, "Having the unique combination
of BMEYE and Masimo rainbow SET in the now FDA-cleared ccNexfin means that
U.S. clinicians have access to a new way of continuously, completely
noninvasively monitoring the hemodynamic status of patients at all points
along the care path."

About BMEYE

BMEYE, a Dutch company based in Amsterdam, The Netherlands, develops
innovative medical devices with broad application in clinical settings that
require cardiovascular monitoring. Specifically, BMEYE produces patient
monitors that noninvasively measure continuous blood pressure and cardiac
output. BMEYE's mission: BMEYE is the premier provider and will set the
standard of noninvasive, beat-to-beat, user-friendly cardiovascular
monitoring systems, to improve patient care and reduce healthcare costs.

Media Contacts: Rob de Ree, BMEYE B.V., +31-207512410

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