Update, September 14, 2020 (12:00 PM ET): The original article below suggests it could be November or even December before we see the Fitbit Sense EKG feature. Fitbit confirmed this, however Android Authority Today the feature will actually be available until October 2020.
Fitbit announced that it has received 510 (k) clearance from the FDA, as well as CE marking in the European Union for the sense. This means that buyers in these areas don’t have to wait long before they can use the EKG function.
The ECG monitor allows users to be alerted to problems such as atrial fibrillation (AFIb) at an early stage.
Original article, Aug. 26, 2020 (2:00 p.m. ET): Fitbit has done a lot with the EKG heart sensor in its Sense smartwatch, but when can you use it? Fortunately, you probably don’t have to wait too long.
Fitbits Devices VP Larry Yang said Wareable that the EKG was in the “final review” process with the FDA and would receive approval in both the US and the European Union “this side of the holiday”. An additional spokesman added that the company cannot provide a specific date.
Fitbit Sense EKG: Why the Delay?
This does not guarantee that the EKG functionality will be available once Fitbit receives the clearance. Fitbit still needs to provide updates to turn the feature on. However, this suggests that you don’t have to wait until 2021 to check for signs of possible heart irregularities like atrial fibrillation.
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While you may have to wait months for functionality, that delay is all too common for EKG functions on smartwatches. The Apple Watch Series 4 ECG sensor could not be used in the US until December 2018, months after it launched. It took even longer to reach other countries. The Galaxy Watch 3’s sensor has FDA approval but has not yet been activated in the US. And how Wareable Withings has problems getting ECG approval for devices like the ScanWatch despite months of waiting.
Due to the nature of the exam, intervals can be very long. Even a minor change during development could require a new clinical study, making it difficult to predict exactly when officials will approve the medical device. This is important for an EKG sensor that can trigger a doctor’s visit. However, it can be frustrating when you want to take full advantage of your watch’s features.