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Medical Devices / Submissions and Approvals

FDA Clears Wearable Patient Monitoring Device

Feb. 8, 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.

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