EarlySense Receives FDA Clearance and CE Approval

EarlySense, which is currently bringing to market the most advanced, contact-free, patient monitoring solution for hospitals and nursing homes, announced today that it has received FDA clearance and CE approval for the 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 contact-free patient monitoring system, which was FDA cleared and CE approved in 2010, automatically and continuously monitors a 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 significant 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 says, "One of our goals at EarlySense is to continuously improve on the ease of use and installation of our solution, while simultaneously adhering to the strictest protocols on data integrity, security and privacy. The WiFi communication system makes installation extremely simple, as it eliminates the need for a hardwired infrastructure network. This means, that our patient monitoring system is not only contact-free, in terms of never touching the patient, but is now also almost infrastructure-free.”

EarlySense also announced today that the company has received an ISO 13485 Certificate. This confirms the company’s compliance with the highest international regulatory requirements.

“ISO 13485 approval is a very important milestone for us. Receipt of this status reaffirms EarlySense’s commitment to the highest level of quality both in the design and manufacturing of our patient monitoring system as we continue to serve our customers with creative, cutting edge solutions,” says Dalia Argaman, EarlySense’s vice president of clinical and regulatory affairs.