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."
The U.S. Joint Commission recently issued a Sentinel Event Alert, which warned on safe use of opioid analgesics and recommended implementing better dosing along with oxygenation and ventilation monitoring in post-surgical patients. The alert said improper use of opioid analgesics may cause adverse effects and potentially lead to death, according to the press release.
The EarlySense system is already in use by hospitals across the U.S. and Europe to help clinical teams prevent falls and pressure ulcers, said Dalia Argaman, VP of clinical and regulatory affairs.
EarlySense will introduce the new systems at Medica 2012 in Germany next month and officially launch the systems in 2013, according to a company statement.
