Fitbit Sense ECG Sensor Gets FDA Approval, To Be Available in October

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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.

Fitbit Sense gets FDA approval for ECG sensor

(Photo : Fitbit)
Fitbit Sense gets FDA approval for ECG sensor

This feature will be available in October with the FDA approval, although the Sense will be shipped starting September with an inactive ECG sensor.

Fitbit co-founder and CTO Eric Friedman aim to help people understand and manage their heart while the new ECG app could assist those users who want to assess themselves while their doctor reviews the reading later.

"Early detection of AFib is critical, and I'm incredibly excited that we are making these innovations accessible to people," Friedman said adding that the device could help people worldwide to improve their heart health while preventing more serious conditions and save lives.

AFib is a heart condition that affects more than 33.5 million people globally, which caused serious complications like stroke. Strokes occur when the blood path to the brain is blocked by a blood clot or plaque, which is a fatty deposit in the blood vessel lining.

It is really hard to detect because the heart does not always show an abnormal rhythm during check-ups. However, the device's ECG monitor can detect abnormal heart rhythm or the AFib, which warns about serious health conditions such as stroke and heart disease.

Fitbit Sense Price and Features

Earlier this year, Fitbit primarily focused on fitness trackers with the launch of Charge 4. This fall, the company now offers an advanced health smartwatch. Fitbit Sense is available at $329, which includes new hardware such as an electrodermal activity (EDA) sensor as well as new features like an ECG sensor.

Fitbit Sense

(Photo : Fitbit )
Fitbit Sense

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

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