FDA grants EarlySense marketing clearance for EverOn Touch system

Jun 21 2010

EarlySense announced today that its EverOn Touch system has been cleared for marketing by the U.S. Food and Drug Administration. The FDA clearance covers several key additions to the traditional EverOn contact-free patient supervision system value proposition. For the first time, the EverOn system includes an online display that alerts medical staff regarding a patient's motion level and verifies patient turns as indicated by nurses. Identifying low patient movement and then turning patients methodically are key elements in the prevention of pressure ulcers, the most costly patient safety risk in U.S. hospitals.

"Today's FDA clearance news further validates our technology. We have repeatedly heard from our partner hospitals that preventing pressure ulcers is a critical need due to the enormous burden pressure ulcers place on hospital budgets and the huge task of preventing them. The addition of pressure ulcer prevention support capabilities to a system that already delivers vital sign detection and bed exit alerts further enhances the EverOn as a full contact-free patient safety suite for hospitalized patients," said Mr. Avner Halperin, CEO of EarlySense.

"The EverOn Touch system incorporates feedback we have received from our clinical sites requesting a more convenient touch screen interface as well as more comprehensive patient motion monitoring, especially as it relates to patients at risk of pressure ulcers and falls. The FDA clearance strengthens our belief 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.

The newly cleared features augment the previously FDA-approved EverOn contact-free, patient supervision system which utilizes a sensor placed underneath a hospital bed mattress. There are no leads or cuffs to connect to the patient, who has complete freedom of movement and is not burdened by any irritating attachments. The system measures patient vital signs and movements and alerts medical personnel of the changes in a patient's condition. EverOn detects heart and respiration rates, bed entries and exits. Clinical evaluations performed worldwide with EverOn show significant improvement in clinical and economic outcomes for hospitals using the system.