BMEYE ccNexfin and Masimo Rainbow SET Pulse CO-Oximetry technology receive CE Mark certification

BMEYE B.V., the innovators of combined noninvasive, beat-to-beat blood pressure and cardiac output monitoring, and Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, jointly announce today CE Mark certification and the European launch of the BMEYE ccNexfin—the first noninvasive cardiovascular monitor with Masimo Rainbow SET Pulse CO-Oximetry technology.  The combination of two innovative noninvasive technologies—BMEYE for cardiovascular monitoring and Masimo Rainbow SET for 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.  

The ccNexfin with Masimo Rainbow SET offers some of the most advanced cardiovascular monitoring capabilities available today.  It utilizes a single sensor finger cuff (BMEYE) and finger sensor (Masimo Rainbow SET) 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), derivative of pressure (dP/dt), noninvasive hemoglobin (SpHb), oxygen saturation (SpO2), 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 is a unique noninvasive, beat-to-beat, and user friendly cardiovascular monitor that delivers a patient's full hemodynamic profile based on real-time data," stated Rob de Ree, CEO of BMEYE.  "Masimo Rainbow SET Pulse CO-Oximetry plays an integral role in the delivery of this rich hemodynamic data stream by providing critical information about oxygen delivery at the tissue level, which is an essential component of accurate hemodynamic assessment."

Assessment of hemodynamic status is a cornerstone of critical care medicine, routinely used to evaluate, diagnose, and direct therapy to manage the care of at-risk and critically-ill patients.  Hemodynamic monitoring—the direct measurement of blood pressure inside the veins, heart and arteries in relation to cardiac output and systemic vascular resistance—allows clinicians to assess the cardiovascular system and identify early circulation changes that reflect small changes in the way the heart is working to deliver blood and oxygen to tissues and organs.  

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. The integration of ccNexfin and Masimo Rainbow SET technologies into the emergency department, intensive care units, and anesthesiology care areas has the potential to facilitate earlier diagnosis and the delivery of protocol- and goal-directed therapies that improve patient safety and clinical outcomes.  

Masimo Founder and CEO, Joe Kiani, stated, "The risks and costs associated with invasive hemodynamic monitoring techniques leaves many high-risk patients underserved at a time when assessing hemodynamic stability is most needed.  The synergistic combination of BMEYE and Rainbow SET means that continuous, noninvasive hemodynamic monitoring can benefit more patients at all points along the care path."