CE mark

CardiacSense’s Medical Watch Gets CE Mark for A-Fib and HRV

February 11, 2021

CardiacSense has received CE mark certification clearing its medical watch for detecting and monitoring atrial fibrillation (A-Fib) and heart-rate variability (HRV).

The device is now cleared for use in continuously monitoring A-Fib and HRV without the need for cardiac-monitor implants. The watch provides 24/7 monitoring and connects to the patient’s mobile phone via Bluetooth.

The company said that it has also launched clinical trials to support regulatory clearance for additional vital signs, including continuous respiratory rate, core temperature, oxygen saturation, blood pressure and other arrhythmias.

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