FDA grants marketing clearance for EarlySense's EverOn Central Display Station

EarlySense announced today that its EverOn Central Display Station (CDS) has been cleared for marketing by the U.S. Food and Drug Administration (FDA). The FDA clearance covers the ability of the system to collect real time vital sign information from up to 36 EverOn bedside monitors and display the information on a computer screen at the nurse's station. This data is also replicated on large LCD displays on the medical surgical floors enabling the clinical teams, as they move from room to room, to continuously and actively observe the condition status of their various patients and any corresponding patient safety alerts. The data is collected by the EverOn system's contact-free sensor placed under the hospital bed mattress. It has no leads or cuffs and never touches the patient.

"Today's FDA clearance news allows us to provide hospitals with a comprehensive solution that enables proactive patient care. This is achieved by delivering critical vital sign and patient safety information from the bedside to the nurses and physicians, wherever they are. With today's increased focus on improved quality and patient safety targets coupled with the challenges of shrinking budgets, hospitals are turning to advanced technologies such as EverOn to provide effective alerts on high risk situations," said Mr. Avner Halperin, CEO of EarlySense.

The Central Display Station is a vital part of EarlySense's EverOn patient monitoring system. It continuously presents and transmits the respiratory and heart rate data of patients. In addition, it displays bed exit alerts for preselected patients. This information helps to minimize falls. Furthermore, the CDS alerts nurses when the system has determined that patients, who are under a pressure ulcer prevention program, need to be turned. This helps nurses to more proactively attend to these patients. Finally, EarlySense's EverOn system is now becoming an integral part of the nurses' workflow as, via the CDS, it sends relevant alerts to the mobile phones of the nurses, enabling real time notification of any adverse changes in a patient's vital signs.

"The Joint Commission national patient safety goals 9, 14 and standard of care PC.02.01.19 require hospitals to reduce patient falls, pressure ulcers, and have a process for early recognition of patient deterioration. A continuous monitoring system that alerts on patient vital signs, bed exits and turns is a crucial tool in proactively complying with these guidelines," said Dalia Argaman, vice president of clinical and regulatory affairs at EarlySense.

The newly cleared CDS augments the EverOn contact-free, patient supervision system approved in June 2010. Clinical evaluations performed worldwide with EverOn show significant improvement in clinical and economic outcomes for hospitals using the system.

SOURCE EarlySense