FDA Clears the EverOn Patient Supervision System from EarlySense

The U.S. Food and Drug Administration (FDA) has cleared the EverOn Touch system from EarlySense for marketing. The clearance from the FDA encompasses major additions to the value proposition of conventional contact-free EverOn patient supervision system.

The new EverOn Touch system incorporates an online display, which warns clinical staff of the level of movement of a patient and checks patient turns against that suggested by nurses. Decreased movement of the patient is detected and the patient is turned systematically. These are major factors preventing pressure ulcers, which are the most expensive safety risk for hospitalized patients in the U.S.

The new features enhance the FDA-approved earlier version of EverOn patient supervision system, which incorporates a sensor kept beneath a hospital bed. Patients are not connected to cuffs or leads. The patient is free to move without any attachments. The supervision system monitors the movements and vital signs of the patient and alerts medical staff of any change in the condition of a patient. EverOn keeps track of bed entries and exits and respiration and heart rates. Global clinical experiments conducted using EverOn reveal major improvement in clinical results and cost-effectiveness for hospitals where the system is used.

EarlySense’s CEO, Avner Hollering, said that the FDA clearance validates the company’s innovative patient monitoring system. He added that hospital staff, in general, feel that the prevention of pressure ulcers is crucial in bringing down hospital budgets. According to him the earlier EverOn patient supervision system has been now enhanced with the inclusion of support capabilities for pressure ulcer prevention, which offers a contact-free safety suite for hospitalized patients.

The Vice President of clinical and regulatory affairs of EarlySense Dalia Argaman noted that the EverOn Touch system has been launched in view of the need for a better touch screen interface and comprehensive motion monitoring in hospitalized patients, and the clearance from the FDA emphasizes the positive impact EverOn will make in enhancing patient care in hospital settings.