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Fitbit Sense ECG sensor approved by FDA, available in October



The U.S. Food and Drug Administration approves the Fitbit Sense smartwatch ECG app on September 14, after company personnel used the device to present an atrial fibrillation rhythm report, also known as AFib. Did.

To meet the FDA’s requirements, Fitbit has shown a study that uses device algorithms to detect 98.7% of AFib cases. In clinical trials, AFib was identified from normal sinus rhythm and generated a record of the electrical rhythm of the heart. It uses 12 leads and the lead I measurement is based on the input from the connected leads. On both arms.

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

This feature will be available in October with FDA approval, but Sense will ship in September with an inactive ECG sensor.

Fitbit co-founder and CTO Eric Friedman aims to help understand and manage the mind, but the new ECG app helps users who want to evaluate themselves while doctors review their readings later. I can do it.

“Early detection of AFib is very important and we are very pleased to make these innovations available to people.

AFib is a heart disease that affects more than 33.5 million people worldwide and has caused serious complications such as stroke. Stroke occurs when the blood pathways to the brain are blocked by blood clots or plaques (fatty deposits in the inner layers of blood vessels).

The heart is very difficult to detect because it does not always show an abnormal rhythm during the test. However, the device’s ECG monitor can detect AFib, which warns of abnormal heart rhythms and serious health conditions such as stroke and heart disease.

Fitbit Sense Pricing and Features

Earlier this year, Fitbit focused primarily on fitness trackers with the launch of the Charge 4. This fall, the company is now offering advanced health smartwatches. Fitbit Sense is available for $ 329. This includes new hardware such as electronic design automation (EDA) sensors and new features such as ECG sensors.

(Photo: Fitbit) Fitbit Sense

Also, the Sense case is made of stainless steel and aluminum, similar to the AMOLED screen, which is slightly larger than other Fitbit smartwatches. It also features built-in GPS, music storage, a new PurePulse 2.0 heart rate monitor, SpO2 sensor, Fitbit Pay support, and built-in speakers compatible with voice assistants. However, the device is not LTE capable.

The EDA sensor records and displays your data on the Fitbit mobile app. It comes with a new stress management score that takes into account your sleep, heart rate and activity data. This means that the higher the number, the better the body is in managing stress physically. This number changes regularly. When the number is low, the device displays some relevant advice on proper stress management, respiratory movements, and other information.

Although Fitbit Sense is considered a medical device, it is very helpful in providing limited and useful data that your doctor can use as a reference.

Also read: Researchers discover a new small antibody called Ab8 that can prevent COVID-19

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