EarlySense lands FDA clearance for its updated monitoring systems
Medical device maker EarlySense integrates oximetry monitoring into its bedside system and central display system, winning FDA clearance for the U.S. market.
Massachusetts-based medical device maker EarlySense received FDA clearance for its oximetry-integrated bedside system and central display system to help the clinicians provide a higher level of supervision for post-surgical patients.
"EarlySense is the first in the world to combine contact-free respiratory, cardiac and motion monitoring with oximetry. This means, that for the first time ever, hospitals have the ability to monitor the oxygen saturation of a patient in addition to automatically, continuously and in a contact-free manner, monitor that same patient's vital signs and movement," CEO Avner Halperin said in prepared remarks. "The oximetry component, meant for post-surgical patients who require a higher level of supervision, seamlessly integrates into the existing EarlySense system, including the central display station. The combination of deliverables provides clinicians with a flexible tool to facilitate individualized care plans for optimal clinical outcomes on the medical surgical floors."