www.fdanews.com/articles/180674-philips-gains-fda-marketing-clearance-for-intellivue-guardian-solution
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Philips Gains FDA Marketing Clearance for Intellivue Guardian Solution
February 27, 2017
Netherlands–based Royal Philips has received FDA marketing clearance for the Philips Wearable Biosensor.
The device is designed to aid clinicians in the early detection of subtle signs of patient deterioration, by measuring heart rate, respiratory rate, posture and detecting falls. The data is then transmitted to the device, which analyzes the measurements over time and notifies the clinician when preset limits are exceeded.
The device received a CE mark in 2016.