[venachescu]

Being cleared by the FDA means that they have demonstrated evidence, which is linked in the original Apple page: https://pubmed.ncbi.nlm.nih.gov/36305584/

Like others have said, it's likely prescription only because being FDA approved as a treatment for a specific disease allows it to be paid by VA or other health insurances.

FDA approval processes and guidelines are notoriously rigid and increasingly antiquated, and likely ended up requiring "the whole system - i.e. watch + app + phone" to be approved together, making the package pretty pricey - and in awesome circular logic now basically require insurance to pick up the tab.

There are some efforts to make "digiceuticals" more streamlined to approve but... the FDA is unfortunately very necessary but painfully in need of reform.