www.fdanews.com/articles/190154-fda-clears-wearable-patient-monitoring-device
FDA Clears Wearable Patient Monitoring Device
February 7, 2019
Current Health’s vital sign monitor, a wireless device that can be worn on the patient’s upper arm, gained 510(k) clearance from the FDA.
The device monitors a patient’s vital signs, including pulse rate, oxygen saturation, movement, posture and temperature, and notifies a healthcare professional when a variable goes above defined parameters.
The monitor non-invasively measures the patient’s vital signs up to every two seconds and transmits the data to the electronic health record.