Fitbit to Launch ECG App in the US and EU in October 2020
Shots:
- Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The ECG app will be available in Oct’2020 to the users on the Fitbit Sense smartwatch
- The company has launched a multi-site clinical trial across the US- to detect AFib from normal sinus rhythm and to generate an ECG trace- recording of a heart’s electrical rhythm- that is qualitatively like Lead I ECG. The study demonstrated that the algorithm has an ability to detect 98.7% of AFib cases (sensitivity) and is 100% accurate in identifying study participants with normal sinus rhythm (specificity)
- Fitbit Sense smartwatch is available today for pre-order on Fitbit.com with WW availability starting later this month and is available for $329.95 in carbon/graphite stainless steel and lunar white/soft gold stainless steel
Ref: Fitbit | Image: Fitbit
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