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LifeWatch AG Files for Premarket Notification for VSP at FDA


Tuesday, 29 Oct 2013 02:00am EDT 

LifeWatch AG announced that it has filed a 510(k) Premarket Notification with the United States Food and Drug Administration (FDA) for regulatory clearance of its new Vital Signs Patch (VSP) technology. LifeWatch also expects FDA approval for its smartphone LifeWatch V in the first half of 2014. The chest patch VSP is a reusable portable device with embedded sensors that attaches to a patient's chest via a disposable adhesive part. The VSP system is an ambulatory patient monitor that enables the continuous and accurate remote monitoring of the vital signs of a patient routinely checked by nursing staff. It automatically analyzes and wirelessly transmits continuous patient data that can be reviewed by healthcare professionals and support coordination of care. 

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11 Jul 2014