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FDA Clearance Granted to EarlySense’s EverOn CDS

EarlySense’s EverOn Central Display Station (CDS) has achieved FDA (U.S. Food and Drug Administration) Clearance.

The CDS is capable of gathering vital statistics and crucial safety data on a real time basis from around 36 EverOn monitors placed by the patient’s bedside and shows the data so collected on computer screens placed in the nurse’s station, and even on the nurses’ mobile phones. The same data can also be shown on huge LCD display screens on medical surgical departments to assist the clinical team moving around the various rooms, to give them the status of their patients, and also patient safety alert signals. The data is gathered by EverOn System’s sensor kept under the hospital bed. It is totally contact-free with no cuffs or leads touching the patient.

According to Mr. Avner Halperin, CEO of EarlySense, the FDA approval of their CDS would help them to supply hospitals with a complete product for proactive patient vigilance. This was done by passing on the critical health care data from the patient’s bedside to the nurses and physicians anywhere in the hospital. Hospitals would prefer to use such cutting edge technological innovations that would also suit their dwindling budgets to achieve patient safety targets, enhanced quality and increased efficiency.

The core of EverOn’s system is the central display station, where data such as heart rate etc are transmitted continuously along with bed exit alerts for a few chosen patients helping to reduce patient falls. It also alerts the nurses, when a patient undergoing a pressure ulcer prevention procedure needs to be turned the other way in the bed. Thus nurses can attend to the patients in a highly proactive manner. The alerts which the CDS sends to the mobile phones of the nurses tells them about any crucial change in the patient’s condition.

Dalia Argaman, Vice President, EarlySense (clinical and regulatory affairs), stated that to achieve the Joint Commission national patient safety goals in reference to rules 9, 14 and also rule pc.02.01.19, patient falls and pressure ulcers must be reduced, and also quick identification of a patient’s deteriorating condition is a must. All this could be achieved by using a real-time monitoring system such as the CDS.

The CDS boosts the June 2010 approved EverOn contact-free, patient supervision system, proving that this system is both economically and clinically viable.

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