Fitbit has received regulatory approval for the ECG app on the Fitbit Sense smartwatch, and will be available to users in countries in India, the US and Europe from next month. The Fitbit Sense was recently unveiled by the company, but the electrocardiogram (ECG) app on the smartwatch did not receive regulatory approval. The ECG is a measurement of the heart’s electrical activity, and the app allows users to take on-the-spot readings of their heart rhythm.
Fitbit said It successfully received 510 (k) clearance from the Food and Drug Administration (FDA) and the European Union (EC) marking in the European Union, marking the European Union for its ECG application Fitbit sense Clever watch. Through the ECG app, users can assess their heart rhythm for arterial fibrillation (AFIB), an irregular heart rhythm that increases the risk of heart-related complications.
Fitbit A multi-site clinical trial was conducted in regions across the US as part of the submission process to regulatory agencies. According to a press release by Fitbit, the study demonstrated the ability of the ECG app to detect 98.7 percent of AFIB cases (sensitivity) and was 100 percent accurate in identifying study participants with normal sinus rhythm (specificity) .
Fitbit sense that was Launched Last month also has an EDA used for stress management and Fitbit claims that it is the first for any wearable. It provides a stress management score that will tell users how their bodies respond to stress based on health metrics such as activities, heart rate, and sleep patterns.
The smartwatch features a large AMOLED display with ambient light sensor. According to Fitbit, its new PurePulse 2.0 technology that uses an in-built heart rate sensor will be able to notify the user when the heart rate becomes too slow or too fast.
The Fitbit Sense also comes with a new skin temperature sensor which can apparently detect early signs of fever or the onset of new menstruation. It will also monitor the temperature of the skin. The smartwatch can also detect a user’s SpO2 levels during the day.
The Fitbit Sense is priced at Rs. 34,999, and will be available in India in the fourth quarter of 2020. Apart from India, the Fitbit ECG app on Fitbit Sense will be available to Fitbit users in the US, UK, Germany, Austria, Luxembourg, Netherlands in October 2020. , Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France and Hong Kong.
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