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Masimo Initiates Limited Market Release of E1, Single-Patient-Use Ear Sensor for Pulse Oximetry Monitoring

Thu, 06/02/2011 - 12:34pm
Bio-Medicine.Org

IRVINE, Calif., June 2, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today FDA 510(k) Clearance, CE Mark, and limited market release of the industry's first single-patient-use ear sensor.  Compared to digit sensors, the Masimo E1™ enables faster detection of oxygen saturation changes during low perfusion due to a variety of clinical factors, including sedative or medication-induced vasoconstriction.(1,2,3)  Compared to reusable ear sensors, it also avoids cross-contamination risks for patients and reduces the complexity of sensor management for clinicians, including cleaning, storage, and transport.  In the limited market release, select clinicians around the world will have the opportunity to use and evaluate the performance and benefits of the E1 sensor.(Photo:  http://photos.prnewswire.com/prnh/20110602/LA12943)

Due to the signal processing limitations of conventional pulse oximetry during challenging conditions, clinicians often seek alternative monitoring sites on the head.  In spite of the established need, available single-patient-use sensors for the head have suffered from unreliability.  While Masimo SET Measure-through Motion and Low Perfusion pulse oximetry overcomes the limitations of conventional pulse oximetry and offers reliable true alarm detection and false alarm prevention during challenging conditions, there are still some advantages to monitoring on the head such as faster response to oxygenation changes during low perfusion and the use of an alternative site when the digit is unavailable.  

As a single-patient-use ear sensor that is placed securely in the cavum conchae (the deep hollow near the ear canal opening), the E1 allows clinicians to combine Masimo SET performance with a reliable alte

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