Google assistant and ECG availability in Germany

[EricTune]

Hello @Fitbit ,

when will Google assistant and EKG be available for the sense in germany?

Thanks!

Eric

Moderator Edit: Clarified subject

[N8teGee]

Hi @EricTune, good to see you in the community.

No one really knows, as it still needs to receive CE approval for the EU. Hopefully this doesn't take too long, but I think it's very much dependent on how quickly it takes the regulatory body to clear it.

"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. Not intended for use by people under 22 years old. See www.fitbit.com/ecg for more details."

[EricTune]

Thanks for that info! Do you also know about google assistant?

Thanks, eric 

[Julia_G]

@EricTune , Fitbit never announces timetables for such matters, so no one knows the answer to that either.

As for the ECG feature Fitbit have not even confirmed whether they have applied for CE approval, so I would not expect availability in the near future.

Google Assistant may be more straightforward, but if it becomes connected to regulatory approval for Google’s purchase of Fitbit that also could lead to delays in availability.

[Marrrmaduke]

@EricTune no official press release on that but VP Product confirmed for Wearable that they have applied. They're hoping to get approved by Christmas. Take it as a leak. Google acquisition should not impact CE approval as CE marking is about the compliance with health, safety, and environmental protection standards.

[Julia_G]

@Marrrmaduke we’ll agree to disagree on this one.  If we get the ECG in the EU before Christmas I will buy you a virtual festive drink - but I don’t think you will be collecting!

[SteveH]

A couple of comments re Google Assistant availability in Germany.

According to https://www.fitbit.com/global/us/technology/voice Germany will be on the initial list of supported countries, but it will not be available on day 1. It says: "Google Assistant coming late 2020"

[Marrrmaduke]

@Julia_G I think trying to guess whether ecg will arrive in EU this year or next is pointless. I think tho we already know the process has been started. Re google assistant I'm not sure what you mean by dependent on google acquisition (paraphrasing). This feature is available on new Fitbit smartwatches and that's pretty much it. 😂 Don't worry I won't be collecting drinks. 😍

ETA: As @SteveH pointed out Assistant won't be available on day 1 in Germany. And my extra two cents - probably again there will be hoopla with listening and recordings. 

[N8teGee]

I'm also under the impression that Fitbit has applied for clearance within the EU, why would we assume otherwise? "We've got the tech, we've got the hardware, now let's just sit on it an not bother applying to the relevant authorities...." Doesn't make much sense to me. They know they need to get this out quickly, the ball will have begun rolling.

Whether it be this side of Christmas or the other, no one really knows. At this point it is out of the hands of Fitbit, although I'm sure the VP in question will have a better idea than any of us. 

[EricTune]

Thanks @All 🙂 

I will than wait until there is an official info and hope for a fast approval. In the notes on the website, fitbit says google assistant won't be available until the end of 2020, so this won't be an initial feature I guess.

[N8teGee]

@EricTune Yes that's correct, GA will be coming late 2020. Alexa will ship with the device though. 

[Julia_G]

I hope you all are right re ECG.  My only point is that no one outside the named areas (USA, Canada and Hong Kong) should assume availability any time soon.  Despite the Wareable article, the official documentation lists only those areas as pending.

[N8teGee · Accepted solution]

The ECG now seems to have been approved in the US and the EU.

Official press release here.

I wonder which festive drink @Julia_G will be buying @Marrrmaduke 😋 😉 

[Julia_G]

My scepticism was based mainly on the fact that Fitbit did not state that ECG was “pending approval” anywhere except US, Canada and Hong Kong, and secondly having worked a couple of decades for a research group that studies European regulatory processes I know quite a lot about how complex approval can be.

However, this article explicitly states that it will be coming. I am super happy to be wrong!  Virtual drink already sent.

 ”SAN FRANCISCO--(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 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 States, United Kingdom, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.”

[Marrrmaduke]

@N8teGee The most expensive one!!🤗❤️😂

ETA: I had to have a private call with Boris and Angela to speed things up, but it all worked out. 😂

[rmeszaros]

Hi,

I don't really understand why this feature will only be available for the listed EU countries despite the received clearance for the whole EU? I live in Hungary and I've just contacted Fitbit's C.S. and the representative said they don't know when and if ECG feature will be available for Hungary (or any other not-listed country). I'm sad about that. I was just about to pre-order. If availability in the future would be granted I would buy it without a thought.

Have you got any idea of the reason of this based on your experience?

Thanks! 🙂

[rmeszaros]

Oh, and another thing: what if I set my phone to english language and my location in the Fitbit app to some of the countries this feature is already available in? Can I "trick" the system this way? What do you think? 🤔

[Marrrmaduke]

@rmeszaros It is because the countries have their own laws as well that the new product needs to comply with. Regarding the tricking part, I remember I had to jump the boarder once to obtain one of the features not yet available in Canada but available in the US. It did work, but I cannot guarantee it will work this time. Best would be to actually wait and see someone else try it.

[rmeszaros]

I see, thanks! So there are two possible scenarios: the Hungarian authorities denied the application or they have not been accepted it yet so it's pending. Ehh... wish I knew which one. 😞

[RB_Swe]

Not so sure about that.

The rules for medical devices are the same within the whole EU (not easy for a ”Canuck” to know this 😉 ) so if a medical device is given an OK for sales in for example in Finland (a EU county) the medical device can be sold in any EU country (and EES country) like for example Germany or Hungary (both EU countries) or Norway (an EES country).

So my guess its a marketing decision from Fitbit, they want the app to be in the native language and most likley a support for Fitbit premium services in the native language before they activate the ECG function in a country.