The U.S. Food and Drug Authority has finally given its approval on September 14 for Fitbit's Sense smartwatch for its electrocardiogram (ECG) app after the company representative showed a heart rhythms report for atrial fibrillation, also called AFib, using the device.
To meet the FDA's requirements, Fitbit showed its study on using the device's algorithm to detect 98.7% of AFib cases. The clinical trial spotted AFib from normal sinus rhythm as well as generated a record of the heart's electrical rhythm, which is comparative to that shown in a regular ECG report, which used 12 leads while its lead-I measurement is based on input from leads attached to both arms.
Also, Sense's case is made of stainless steel and aluminum as well as a slightly bigger AMOLED screen than other Fitbit smartwatches. It also has a built-in GPS, music storage, new PurePulse 2.0 heart rate monitor, a SpO2 sensor, Fitbit Pay support, and a built-in speaker that is compatible with voice assistants. However, the device is not LTE capable.
The EDA sensor records and shows data in the Fitbit mobile app, which comes with a new Stress Management Score, which considers the user's sleep, heart rate, and activity data. This means the higher the number, the better the body is doing at managing stress physically. This number changes regularly, and when it gets low, the device will show some related advice on properly managing stress, breathing exercises as well as other information.
Although Fitbit Sense is considered a medical device, it will be a lot useful in providing limited but useful data that the user's doctor can use as a reference.
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Written by CJ Robles
