Google receives FDA clearance for ECG on Fitbit devices in U.S.

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Google receives FDA clearance for ECG on Fitbit devices in U.S.



Wearable devices are adding more health tracking features all the time, but some advanced functionality requires the same certification and clearances as actual medical equipment. That can mean waiting for governments to approve a feature before it can be (officially) rolled out, and now Google-owned Fitbit has received approval from the U.S. Food and Drug Administration (FDA) for heart rhythm detection.

Google wrote in a blog post on Tuesday, “Fitbit received clearance from the U.S. Food and Drug Administration for our new PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib). The algorithm will power our new Irregular Heart Rhythm Notifications feature on Fitbit.”

Fitbit devices will be able to monitor the changing blood volume in a person’s blood vessels, and use that data to determine a hearth rhythm. With that baseline, wearables can check for irregularities and possible signs of atrial fibrillation, a condition that is associated with increased risk for heart failure, dementia, and stroke. Fitbit’s own study from 2020 reported that its algorithms could identify atrial fibrillation with a 98% success rate, based on data from 455,699 participants over a five-month period.

Samsung received approval from the FDA in 2020 for the same heart rhythm monitoring functionality (also called electrocardiogram, ECG, or EKG) on Galaxy Watches, and Apple was granted clearance in 2018 for its Apple Watch devices. However, smartwatches and wearables won’t replace actual medical devices — they are usually rated as Class II by the FDA, which is a clearance rating and not an FDA approval or endorsement. Fitbit devices appear to have received the same Class II rating, as Google’s blog post mentions the feature is “not intended for use by people under 22 years old,” just like other Class II devices.

Google did not specify which Fitbit products will support heart rhythm monitoring, or an exact timeline for the rollout.

Source: Google


The post Google receives FDA clearance for ECG on Fitbit devices in U.S. appeared first on xda-developers.



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