EarlySense announced today that its EverOn contact-free patient supervision system has been cleared for marketing by the U.S. Food and Drug Administration and has received a CE Mark certification from KEMA, a Dutch notified body, in accordance with the EC-Directive 93/42/EEC. Both allow EverOn for use with children and adults, in a home, hospital or clinical setting. In November 2007, EarlySense announced the FDA clearance of the ES-16, the predecessor of the EverOn system.
EverOn is a wireless patient supervision system installed underneath a bed mattress. There are no leads or cuffs to connect to the patient. The system measures patient vital signs and movements and alerts nurses or caregivers of any change in condition. EverOn detects heart and respiration rates, bed entries and exits, as well as patient movement. EverOn also helps medical staff to better implement patient turns, which can positively influence the treatment and the prevention of pressure ulcers. EverOn’s trend line display is designed to assist clinicians in monitoring the progression of a patient’s health and support improved medical decision making.
“Today’s FDA clearance and CE Mark news further validates our technology. There is an unquestioned need for a system that provides a virtual safety net for patients in hospitals and provides early warnings of physiological changes that may lead to patient deterioration. EverOn enables clinicians to intervene earlier and helps improve outcomes,” said Mr. Avner Halperin, CEO of EarlySense.
EverOn’s advanced sensing and software technology is currently being pre-market tested at leading hospitals and hospital networks in Israel, the U.S. and Europe. The market launch of the device is expected soon.
“Feedback from our principal investigators as well as the approval by the regulatory authorities indicate that the technology is effective, useful and unique in its deliverables. We strongly believe that EverOn will make a positive impact on the future of clinical practice and improve patient care both at the hospital and in post acute care settings,” said Dalia Argaman, vice president of clinical and regulatory affairs at EarlySense.