EarlySense’s WiFi Communication System Receives FDA Clearance

Early Sense, a leading provider of advanced, patient monitoring solutions for nursing homes and hospitals, proclaimed that it has obtained FDA clearance & CE approval for its new wireless network communications component to be used in its monitoring solution. The WiFi system connects the bedside unit to the Central Display positioned at the nurses’ station wirelessly.

The system continuously monitors the vital signs and movements of the patient from the time the patient enters the bed with the help of the contact-free sensor, which is kept under the mattress. The system then documents and records the respiratory, motion and cardiac parameters and sends alerts to staff whenever changes occur in the patient’s condition and even keeps them informed when the patient needs to be turned to prevent pressure ulcers, or if the patient is in danger of falling from the bed. The nurses are kept informed about the changes in the patient’s status on their mobile phones and also on a huge display screen installed on the wall in the nurses department.

According to Avner Halperin, CEO of Early Sense, the company’s goal is to improve its products and make them easier to use and install, all the while following the protocols on security, data integrity and privacy. As there is no hard wired infrastructure network involved, installation of this WiFi system is very simple. He stated that the patient monitoring system is a contact-free and almost infrastructure-free system.

The company has also received an ISO13485 Certificate, proving its compliance with the highest international regulatory needs. Dalia Argaman, Vice President of Clinical and Regulatory Affairs at Early Sense, revealed that the ISO13484 approval is very important to the company as this reaffirms the company’s commitment in adopting high standards of quality in the manufacture of patient monitoring systems.

Source: http://www.earlysense.com


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