Fitbit's AFib detection algorithm gets FDA approval (2024)

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Fitbit's AFib detection algorithm gets FDA approval? ›

Google announced April 11, 2022, that Fitbit received FDA clearance for its photoplethysmography (PPG) algorithm to identify atrial fibrillation (A-fib). The algorithm will power Fitbit's new irregular heart rhythm notification feature. Fitbit's PPG algorithm passively assesses heart rate while still or asleep.

Fitbit has stayed on par with manufacturers like Apple when it comes to launching accurate heart health monitoring. The company received FDA clearance for its ECG app in 2020. Since then, it has pushed this feature to Sense, Sense 2, and Charge 5.

The Apple Watch's atrial fibrillation (AFib) history feature, which records and alerts the wearer's relevant heart events, has been qualified to join the FDA's Medical Device Development Tools (MDDT) program — a first for a “digital health technology.” That means the Apple Watch is now usable in clinical studies that ...

Of those, 98.2% (221/225) showed AFib detections from the Fitbit Irregular Rhythm Notifications software algorithm and the ECG patch at approximately the same time. No serious adverse events were observed during the clinical study.

Your smartwatch can help identify the signs of AFib through an on-wrist assessment with the electrocardiogram (ECG) app on Sense 2 as well as the Irregular Heart Rhythm Notifications on both watches. Both of these tools have FDA and EU clearance and can help inform conversations with your healthcare provider.

In 2020, Fitbit announced that it received clearance from the FDA for its electrocardiogram (ECG) app, which premiered on its Fitbit Sense device (which also included additional health-tracking features like skin temperature and oxygen saturation monitoring).

Majority of doctors would likely endorse the use of Fitbit , but it's not quite the medical appliance it claims to be. Reseach on Accuracy of Fitbit Devices suggests they're accurate enough as a pedometer , less so on other purported uses.

According to Dr. Maged Amine, an interventional cardiologist at Houston Methodist, it turns out that smartwatches with ECG capability can play a role in screening for and monitoring at least one heart condition — atrial fibrillation (AFib), one of the most common types of arrhythmia.

Should I go to the ER if my watch detects AFib? ›

If you ever experience chest pain, pressure, tightness, or what you think is a heart attack, call emergency services immediately. Apple Watch only checks for signs of atrial fibrillation periodically. AFib History may not find every instance of your irregular rhythm.

The best Fitbit tracker is the Charge 6 thanks to its advanced heart rate tracking features and Google apps and services integrations. However, there are many other models that are excellent choices depending on your budget and needs. Here is an overview of how the Charge 6 measures up against other Fitbit models.

The Sense 2 offers a suite of useful health and wellness insights that put it on par with some of the best in the industry. There's a skin temperature sensor, ECG readings, and a real-time stress tracker.

Samsung Galaxy Watch Active 2-FDA Approved ECG Smartwatch

You can easily enable this feature if you already have an Active2 Smartwatch. Samsung Active2 and Galaxy Watch 3 also track irregular heart bears or heart rhythms, which can be early signs of a stroke, heart attack, or other heart-related complications.

FDA clears wearable ECG patches from Samsung spinout Wellysis, SmartCardia.

We recently discovered a new resource for those living with atrial fibrillation. CardioVisual, which was created by practicing cardiologists to educate their patients, is a free mobile app for iPad, iPhone, and Android.

The Fitbit Irregular Heart Rhythm Notifications feature is FDA-cleared as “a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation and provide a ...

SAN FRANCISCO--(BUSINESS WIRE)--Fitbit (NYSE:FIT) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib), a condition that affects more ...

The Fitbit Charge 5. Google announced earlier this month that its Fitbit was granted clearance from the US Food and Drug Administration for its atrial fibrillation detection algorithm.