Fitbit has completed clinical trials of its own ECG feature and is looking to get FDA approval – as it launches a large scale study into Afib and irregular heart rate detection.
The mass Fitbit Heart Study is part of what the company calls its “broader commitment to heart health,” and the company is hoping to attract hundreds of thousands of users to opt into tracking and detecting heart rhythms on Fitbit devices.
Fitbit confirmed that it “has made significant progress in the development of a new electrocardiogram (ECG) feature for spot detection of AFib.” And that device could launch in 2020, with rumors that the Fitbit Sense could be the company's first ECG device.
“The Fitbit ECG feature is designed to support those who want to screen themselves for possible AFib and record an ECG trace they can review with their doctor.
"The company has completed a pivotal clinical trial of its new ECG feature and plans to seek review by the U.S. Food and Drug Administration (FDA) and global regulatory authorities,” it confirmed.
Ahead of the launch of the ECG feature the company is enrolling volunteers into a huge Fitbit Heart Study.
Once opted-in the photoplethysmography (PPG) technology on the back of Fitbit devices will measure the rate of blood flow from the user’s wrist as usual for the 24/7 heart rate monitoring. However, those enrolled in the Fitbit Heart Study will have their data analysed by a new algorithm that will look for irregularities.
If an irregularity is found, those participants will receive a notification and will then be connected with a doctor for a virtual appointment at no cost – and could receive an electrocardiogram (ECG) patch in the mail to confirm their result.
The study is being headed up by Steven Lubitz, M.D., M.P.H, a cardiologist at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School.
“My hope is that advancing research on innovative and accessible technology, like Fitbit devices, will lead to more tools that help improve health outcomes and reduce the impact of AFib on a large scale,” he said.
The study will be open to those with a Charge 3, Charge 4, Inspire HR, Ionic, Versa, Versa 2, and Versa Lite devices – so a pretty broad spectrum of the current range of Fitbits.
Users will need to be in the US to enrol, and over 22 years of age.
The detection of Afib is an area that Fitbit lags in comparison to Apple, but Fitbit has made it clear that this is just one part of its approach to heart health. Apple introduced an ECG feature back on the Series 5.
However, it may have one advantage for its tracking than Apple – its ability to track during sleep.
“The optimal way to identify irregular rhythm through heart rate tracking technology is to screen when the body is at rest, making assessment overnight, while people sleep, ideal for detection,” the company said in a statement.
And it also talked up the role of battery life – another huge benefit Fitbit possesses over many of its rivals.
“Fitbit wearables have the unique potential to accelerate AFib detection because their 24/7 heart rate tracking is powered by long battery life, which allows users to wear their device for multiple days at a time. This enables long-term heart rhythm assessment, including when users are asleep," the company said in a statement.
The Fitbit Heart Study is open for participants. Check the app for details on enrolling – if you’re interested.
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