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Fitbit’s Sense Smartwatch receives FDA approval for the EKG app



The Heart Monitoring Electrocardiogram (EKG) app on Fitbit’s new Sense smartwatch has been approved by the US Food and Drug Administration (FDA). It can track heart rhythms and check for signs of atrial fibrillation, the most common type of irregular heartbeat.

“Our new EKG app is designed for users who want to evaluate themselves right now and review the reading with their doctor later,” said Eric Friedman, co-founder and chief technology officer at Fitbit, in a statement.

Atrial fibrillation puts you at increased risk of stroke and other heart diseases. Wearable devices can continuously monitor people throughout the day and may indicate a problem that a traditional heart monitor (which only measures heart rate at specific times) may have missed.

This is the third wearable app to receive FDA approval for an EKG feature. The Apple Watch was the first in 201

8, and Samsung announced it received the designation at its Unpacked event in early August.

Because these types of devices are classified as low risk, they do not go through a formal approval process that requires extensive testing. The FDA cleared the scythe in a way asking companies to show that their new device is similar to products already on the market.

The release took place on time for the planned start date of the Sense at the end of the month. Other companies weren’t so lucky: Samsung built an EKG function into last year’s Galaxy Watch Active 2 for the first time, but it couldn’t be activated in the US at the time. It’s not clear if or when people with this version in the US can use it. The updated Galaxy Watch 3 has the app, but Samsung hasn’t said when it will be available to US users. Withings has two smartwatches with ECG functions, but it is not FDA approved and therefore cannot be sold in the USA. (They are available in Europe.)

Fitbit conducted a small study of its software last year that found it could accurately detect 98.7 percent of atrial fibrillation cases. In May, the company announced it would conduct a larger study to continue evaluating how well its devices can detect atrial fibrillation. Fitbit will contact anyone in the study with an irregular heartbeat and connect them to a doctor who will check if they actually have the disease. The study aims to enroll hundreds of thousands of participants.


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