Which facts? I was wrong about the evidence needed for marketing authorization but, if I’m not mistaken, they would need that authorization in order to market the product in the first place so mentioning the FDA authorization would, in my opinion, potentially give people the wrong impression that the FDA has endorsed the product at a level (e.g. approval) which I don’t believe the FDA has done at this point.
They went through "De Novo" premarket review as their medical device was distinct from any previous devices. This is a higher standard than the normal "510(k)" process. Both tracks involve a lot of evidence, a lot of documents, and a lot of scrutiny from the FDA.
They went through the harder track of FDA approval for medical devices.
I have no idea why you seem to think the primary way for the FDA to approve of new treatments is somehow... not them approving of it?
The wording is really poor. "Pre-market authorization" is their approval process. As in, you don't get to tell anybody that your device has any medical benefit unless we've assessed it.
