Fitbit gets regulatory clearance in US, Europe for ECG app
W
earables brand Fitbit on Monday announced that it has received clearance from the US Food and Drug Administration (FDA), as well as the Conformite Europeenne(CE) marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib).
Fitbit's on-device compatible ECG app aims to help analyse the heart's rhythm for signs of AFib. ECG is a measurement of the electrical activity of the heart, and with the Fitbit ECG App, people can take an on-the-spot reading of their heart rhythm at any time, including whenever they notice any unusual cardiac symptoms.
"Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor," Eric Friedman, Fitbit co-founder and CTO, said in a statement.
The Fitbit ECG App, unveiled in Fitbit's recent fall product launch, will be available from October 2020 onwards to users on Fitbit Sense in the following countries the US, the UK, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.
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.
As part of the submission process to regulatory agencies, Fitbit conducted a multi-site clinical trial in regions across the US.
The study evaluated our algorithm's ability to accurately detect AFib from normal sinus rhythm and to generate an ECG trace, or recording of a heart's electrical rhythm, that is qualitatively similar to a Lead I ECG.
✔️ Fitbit gets regulatory clearance in US, Europe for ECG app
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