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

Masimo 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. 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.