Fitbit receives EKG authorization for Europe, and its function reaches the watches in Romania


Fitbit has taken an important step in the mainstream introduction of EKG function on its laptops, obtaining approval to use it in Europe and the USA. Generally such functionality needs approvals from the medical community and authorities before the onset. We find that in Romania we will have EKG on Fitbit watches and bracelets and we have details below.

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The authorizations came from the FDA in the USA (Food and Drug Administration), but also through the EU brand, European Conformity. The electrocardiogram function (EKG or ECG) analyzes changes in heart rate to detect atrial fibrillation, a disease that affects more than 33.5 million people worldwide. Romania is among the first countries where the position will be available. The Fitbit EKG application, but also the FitBit Sense device will be able to be used by our users, in Romanian, on iOS and Android.

We will be able to access this news in our country in October. Other countries where Fitbit offers EKGs are the USA, the United Kingdom, Germany, Austria, the Netherlands, Sweden, Switzerland, the Czech Republic, Poland, Belgium, Italy, France, Spain and India. Heart disease is the number one cause of death globally, even if it can be prevented. Atrial fibrillation is an irregular heartbeat that can cause strokes. The problem is that fibrillation is very difficult to detect, because it has no symptoms.

To get the EKG application approved by regulatory agencies, Fitbit conducted a large clinical trial in several regions of the United States. The study assessed the extent to which the Fitbit algorithm can distinguish atrial fibrillation (FibA) from normal sinus rhythm. Well, the Fitbit EKG detected up to 98.7% of FibA cases. Fitbit Sense is the company’s first device compatible with an EKG application. This is also the world‘s first watch with EDA sensor, which measures the response of electrodermal activity to analyze the level of stress.

The EKG analysis of the watch can be downloaded and sent to a doctor. It can be ordered from eMAG.

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