Fitbit Sense’s ECG feature gets FDA, CE approval

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Fitbit is about to launch its previously announced new smartwatch called Sense and just in time, they have good news for those planning to get the wearable. They have received approval from the U.S Food and Drug Administration (FDA) and the European Union’s Conformite Européenne (CE) for the electrocardiogram (ECG) app on the device that would measure a user’s heart rhythm for atrial fibrillation (AFib). This means those who buy the Fitbit Sense at the end of the month will be able to use this important feature at launch.

Heart disease is still the leading cause of death globally but it is actually preventable if you had the right tools, regular checkups, and those who are prone to it will take better care of themselves. AFib which is basically an irregular heart rhythm can be hard to detect since those who suffer from it can be asymptotic most of the time. Wearables started introducing ECG measuring tools but the feature itself has to go through regulatory approval.

Now that they have approval from both the FDA and the CE, the on-device compatible ECG app will be able to analyze your heart rhythms. This is one of the important things that you have to do if you have a history of heart disease in your family and if your doctor says you have to monitor your heart activity. Fitbit Sense is only the third watch to receive FDA approval in the U.S. for an ECG feature, with Apple Watch being the first and Samsung getting theirs in early August.

They actually don’t go through the formal approval process since it’s relatively low risk. The FDA signs off on companies by allowing them to show that their device is similar to other products that are already in the market. Fitbit is pretty lucky they got the approval before the actual launch date unlike Samsung which didn’t get the clearance when it launched the Galaxy Active 2 and now hasn’t said yet when the feature will be available for Galaxy Watch 3 users.

The Fitbit Sense is still on pre-order mode now at Fibti.com and other online resellers. It will be available later this month and will cost you $329.95 and you can choose between carbon/graphite stainless steel or lunar white/soft gold.

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