BMEYE ccNexfin receives FDA clearance

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."