Submitted by kBLASTER Team on
Neuhausen am Rheinfall/Switzerland, December 22, 2014 – LifeWatch AG (SIX Swiss Exchange: LIFE), a leading provider of medical solutions in remote cardiac monitoring, announces that it has received 510(k) clearance from the FDA (U.S. Food and Drug Administration) for its Vital Signs Patch (VSP). The VSP is an easy-to-use sensor worn on a patient’s upper chest. It is intended to be used on adult patients in a clinical environment for the continuous, non-invasive monitoring of ECG, Heart Rate, respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional. LifeWatch expects to launch the VSP in Q3/2015.
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