EarlySense patient monitor system gets FDA marketing nod

The device is cleared for use with children and adults, in a home, hospital or clinical setting.

Medical device EarlySense announced today that its EverOn contact-free patient supervision system has been cleared for marketing by the US Food and Drug Administration (FDA), and has received a CE Mark certification from KEMA, a Dutch notified body.

Both allow EverOn for use with children and adults, in a home, hospital or clinical setting.

In November 2007, EarlySense announced FDA clearance for 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.

Ramat Gan-based EarlySense CEO Avner Halperin called the system a virtual safety net for patients in hospitals, and added that EverOn enables clinicians to intervene earlier. The product is being pre-market tested at hospitals and hospital networks in Israel, the US, and Europe. The market launch of the device is expected soon.

Published by Globes [online], Israel business news - www.globes-online.com - on June 8, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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