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LifeWatch Gets FDA Go-Ahead for Vital Signs Patch

December 23, 2014

Swiss remote cardiac monitoring company LifeWatch has received FDA clearance for its Vital Signs Patch for remote patient monitoring. The reusable device attaches to a patient’s chest via a disposable adhesive strip and monitors heart and respiration rates, temperature, blood saturation and movement using embedded sensors.

The device’s small size, easy application, comfortable and wire-free design allow it to replace multiple devices at a more affordable price, LifeWatch says. The company expects VSP to be used in hospital, ambulance, nursing care and home environments.

The patch is part of a larger VSP system that includes software for saving and transmitting data, a blood pressure-monitoring cuff, and a smartphone with apps to analyze and transmit data, generate reports and alerts and provide location information.

The 510(k) clearance is currently just for the patch. LifeWatch expects clearance for the full VSP system in 2015, with possible market launch in the third quarter. — Kellen Owings

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