EarlySense has received the US food and Drug Administration (FDA) and CE mark approval for its new wireless (WiFi) communications component of its solution.
The WiFi system wirelessly connects the bedside unit of the solution to the Central Display System at the nurses’ station.
EarlySense’s already FDA cleared and CE approved contact-free patient monitoring system monitors patient’s vital signs and movement, from the moment the patient enters the bed, using a contact-free sensor that is placed under the mattress.
The system records and documents the cardiac, respiratory and motion parameters for a full hospital unit.
It alerts staff when changes in a patient’s condition take place, as well as when a patient needs turning to avoid pressure ulcers or is leaving the bed and is in danger of falling.
Nurses are informed of patient status changes on the patient’s bed side monitor, at the nurse’s station, on their mobile phones and on a large screen display mounted in a prominent spot on the wall in the department.
EarlySense CEO Avner Halperin said the WiFi communication system makes installation simple, as it eliminates the need for a hardwired infrastructure network.
EarlySense also received an ISO 13485 certificate.
EarlySense clinical and regulatory affairs vice president Dalia Argaman said receipt of this status reaffirms EarlySense’s commitment to the level of quality both in the design and manufacturing of patient monitoring system as they continue to serve their customers.