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ECG feature in the US

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‎09-02-2020 05:45

‎09-02-2020 05:45

I seen questions asked about whether the ECG will function in other countries. Am I correct that Fitbit has not received approval to activate the ECG feature in the US as well?  

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‎09-02-2020 06:09

‎09-02-2020 06:09

That's correct. The press release says:

 

"FDA review of compatible ECG app pending; only available in the U.S. upon clearance. Availability outside the U.S. pending applicable regulatory clearances including approval under Directive 93/42/EEC (the Medical Device Directive). The ECG app has not yet received a CE mark and will not be marketed, put into service or otherwise made available in the EU until it has obtained regulatory approval"

 

 

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‎09-02-2020 06:09

‎09-02-2020 06:09

That's correct. The press release says:

 

"FDA review of compatible ECG app pending; only available in the U.S. upon clearance. Availability outside the U.S. pending applicable regulatory clearances including approval under Directive 93/42/EEC (the Medical Device Directive). The ECG app has not yet received a CE mark and will not be marketed, put into service or otherwise made available in the EU until it has obtained regulatory approval"

 

 

Best Answer