I wonder what point does a developing technology device get the green light to qualify as a legitimate medical device accessible to the general public thru financial coverage by common insurance companies?

The reason this intrigues me is because I'm thinking about what the path something like this would take and how similar it could be to something like an insulin pump. Or not even as established of a technological advancement as an insulin pump, a better comparison would be the constant glucose monitors. They did not exist when I last had an endocrinologist, but since getting a new dr., I was given one to try out, fell in love with it, got a script for them sent to my pharmacy, but then was brickwalled by the insurance company's coverage of the device. It wasn't that its not covered, when the Dr sent the script, they told me Walmart will need to be walked thru how to process the script so the insurance would cover the cost more appropriately. The way Walmart did it without help, it came to approximately $1000 I had to pay. The Dr said to expect that and they would show Walmart how to fill it so I only paid my normal copay.

Fyi: I'm just thinking out loud and figured I'd share this context in the comments incase any industry professionals care to chime in on what the work flow looks like for a new technological device to become a covered medical device to insurance companies. Lol I don't mean for this reply to trigger you to spend anytime looking into answers to my questions. Cheers tho on the info you already gave me!🍻