Fitbit Awarded Regulatory Clearance in U.S. and Europe for ECG App to Identify AFib

Advertisement

BEGIN ARTICLE PREVIEW:

What You Should Know:

– Fitbit has received 510(k) clearance from the
FDA, as well as CE marking in the European Union, for its ECG
app to assess heart rhythm for atrial fibrillation. The Fitbit ECG App is a
simple way people can take an on-the-spot reading of their heart rhythm at any
time, including whenever they notice any unusual cardiac symptoms. 

– Fitbit Sense is the company’s first device compatible
with an ECG app that enables users to take a spot check reading of their heart
that can be analyzed for the heart rhythm irregularity AFib.

– Fitbit Sense is available today for pre-order on
Fitbit.com and online at select retailers for $329.95 (USD) in carbon/graphite
stainless steel and lunar white/soft gold stainless steel.

Fitbit 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 than 33.5 million people globally. The
Fitbit ECG App, unveiled in Fitbit’s recent fall product
launch, will be available in October 2020 to users on Fitbit
Sense in the following countries: the United …

END ARTICLE PREVIEW

READ MORE FROM SOURCE ARTICLE