Ann: Commercial Partnership with Mobvoi for New Health Smartwatch, page-278

I agree, the statement that fda clearance was not required because it's not being marketed as a medical device, is pretty clear that it was never meant to be a medical device.

Like you pointed out, the reason a lot of shareholders are angsty is because this company has a history of very poor shareholder communication. We literally don't know for sure that our algos made it into the watch. We don't know how long (at least not to my knowledge) they are planning on collating and analysing data, and whether wearers have to authorise this sharing of data. I am also curious about what the third party data sharing requirements will be. Does the data get anonymised before reading CardieX?

The Arty system will have privacy stuff already sorted, but this is a different scenario.

My thought is that this company is being run by someone/s who only see the big picture, and see things like reporting requirements and shareholder information as nuisances. Could be wrong.