Fitbit's AFib app gets FDA clearance, will be available in October: 4 details


Fitbit received FDA 510(k) clearance for its electrocardiogram app to assess heart rhythm for atrial fibrillation.

Four details:

1. The Fitbit ECG app will be available in October on the Fitbit Sense device in the U.S. as well as several other countries.

2. Fitbit conducted multisite clinical trials in the U.S. to evaluate its algorithm, designed to detect AFib from normal sinus rhythm and generate ECG trace. The study showed the algorithm exceeded target performance and showed the ability to detect 98.7 percent of AFib cases; it was also 100 percent accurate identifying normal sinus rhythm in study participants.

3. Users can also take spot check readings of their heart to analyze for AFib by holding their fingers to a stainless steel ring on the watch for 30 seconds; they can download their results to share with physicians.

4. Fitbit Sense costs $329.95 and can be purchased online or in retail stores in late September.

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