Google-owned Fitbit gets US FDA approval for AFib detection


(IANS) Google-owned wearable brand Fitbit on Monday received clearance from the US Food and Drug Administration (FDA) for its new health feature that can detect atrial fibrillation (AFib) — a health tool that made Apple Watch highly popular and which has saved several lives in the past.

AFib is a form of irregular heart rhythm that affects nearly 33.5 million people globally, and individuals with AFib have five times higher risk of stroke.

“Our new PPG AFib algorithm can passively assess your heart rhythm in the background while you’re still or asleep. If there’s anything that might be suggestive of AFib, you’ll be notified through our Irregular Heart Rhythm Notifications feature,” Google said in a statement.

The Fitbit PPG-based algorithm and Irregular Heart Rhythm Notifications feature will soon be available to consumers in the US across a range of heart-rate enabled devices.

The clinical validation for Fitbit’s PPG algorithm is supported by data from the landmark Fitbit Heart Study, which launched in 2020 and enrolled 455,699 participants over five months, informed Google.

Data presented at the 2021 American Heart Association Scientific Sessions found that the Fitbit PPG detections correctly identified AFib episodes 98 per cent of the time, as confirmed by ECG patch monitors.

“The unique capabilities of Fitbit devices — especially its 24/7 heart rate tracking and long battery life – give it the potential to accelerate identification through long-term heart rhythm assessment,” said Google.

Now, Fitbit’s ECG app, which takes a spot-check approach, allows you to proactively screen yourself for possible AFib and record an ECG trace that you can then review with a healthcare provider.

While, the new PPG-based algorithm allows for long-term heart rhythm assessment that helps identify asymptomatic AFib that could otherwise go undetected, Google said.

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