Masimo Rainbow SET Acoustic Monitoring receives FDA clearance

Dec 1 2009

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse oximetry, today announced FDA clearance of its latest innovation -- Masimo Rainbow SET Acoustic Monitoring(TM)( -- )providing noninvasive and continuous respiration rate (RRa(TM)) that is accurate, easy-to-use, and enhances patient compliance. Masimo Rainbow SET Acoustic Monitoring may enable earlier detection of respiratory compromise and patient distress -- offering a breakthrough in patient safety for post-surgical patients on the general floor. The limited market release, which will begin in December, will allow select hospitals to be the first to benefit from the new technology.

Respiration rate is defined as the number of breaths per minute and is considered a critical vital sign in assessing the physiological status of hospitalized patients. Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia (PCA) for pain management as sedation can induce respiratory depression and place patients at considerable risk of serious injury or death. Although the Anesthesia Patient Safety Foundation (APSF) recommends continuous oxygenation and ventilation monitoring in all patients receiving opioids, current methods for respiration rate monitoring are limited by accuracy and patient compliance.

Masimo Rainbow SET Acoustic Monitoring features an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient's neck to detect upper airway acoustic vibrations on the surface of the skin during the respiratory cycle. Using patented acoustic signal processing that leverages Masimo's revolutionary Signal Extraction Technology (SET), the respiratory signal is separated and processed to display continuous respiration rate.

When Masimo Rainbow SET Acoustic Monitoring is used in conjunction with Masimo Rainbow SET Pulse CO-Oximetry and the Masimo Patient SafetyNet(TM) Remote Monitoring and Clinician Notification System, clinicians can follow key indicators of oxygenation with Masimo gold standard SpO2, ventilation with the breakthrough RRa, circulation with Masimo measure through motion pulse rate (PR), and bleeding with Masimo noninvasive and continuous hemoglobin (SpHb(TM)) - enabling them to monitor more patients, more safely, than ever before.

According to Michael Ramsay, M.D., Chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center in Dallas, Texas, "Breathing adequately is what matters most. Masimo acoustic respiration rate provides clinicians with the ability to automatically and continuously monitor the breathing status of post-surgical patients in general care or post-anesthesia settings -- alerting them to the first sign of an abnormal or compromised breathing pattern that may be indicative of airway obstruction or respiratory distress." After using the new technology, Dr. Ramsay also stated "The Masimo Acoustic Sensor is virtually unnoticeable when worn - making it extremely patient-friendly."

Masimo Founder and CEO, Joe E. Kiani, stated, "Solving 'unsolvable' problems that have plagued patient monitoring is key to advancing medicine and improving patient care. Masimo Rainbow SET Acoustic Monitoring addresses a longstanding and growing need to accurately and easily monitor patient breathing, which is expected to improve patient safety and decrease the cost of care in hospitals. It also adds another compelling reason for hospitals to choose the Masimo Rainbow SET upgradeable platform for pulse oximetry, Pulse CO-Oximetry, and now -- Acoustic Monitoring."

Live demonstrations of Masimo Rainbow SET Acoustic Monitoring will be featured at the Masimo exhibit at the American Association of Respiratory Care December 5-7, 2009 in San Antonio, Texas.

SOURCE Masimo Corporation