Fitbit Sense ECG clears FDA ahead of launch

Joanna Estrada
September 15, 2020

Fitbit announced today via a press release that it had received official regulatory approval from agencies in the US and E.U.to enable its ECG sensors and app on its upcoming Sense smartwatch.

As per a press release shared by the company, Fitbit has successfully received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) and Conformité Européenne (CE) marking in the European Union for its ECG app.

Obviously, the ECG monitor built into a $330 commercial device also featuring a bunch of other sensors may not prove as reliable as a medical-grade system typically found in a hospital, but Fitbit claims the multi-site clinical trial it conducted as part of the submission process to regulatory agencies yielded a stellar 98.7 percent sensitivity score and a flawless 100 percent specificity rating.

Expect the same high-quality education, world-class speakers and valuable business development in a virtual format.

The Fitbit Sense is the company's first health watch and is set to be released on 25 September, and debuts the use of electrocardiogram on a Fitbit device. By holding their fingers to the stainless steel ring on the face of the watch, a user can take a 30-second, single-lead reading of their heart's electrical activity-performing a spot-check if they notice any unusual cardiac symptoms.

Atrial fibrillation can be hard to detect early, before the rapid, abnormal rhythm can lead to serious complications such as stroke, with many people finding out they have afib only after one has occurred.

Fitbit validated its ECG feature in multiple, local studies across the globe. "I've long believed in the potential for wearable devices to help us stay better connected, and use real-world, individual data to deliver more informed, personalized care". According to the study it was able to detect Afib in 98.7% of cases, and was 100% accurate in identifying study participants with normal sinus rhythm. As explained by Fitbit, the main objective is to detect atrial fibrillation (AFib), a condition that affects more than 33.5 million people (!) globally, increasing the risk of complications like stroke.

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