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I believe it's covered up to $200 dollars. But I could be wrong.

The insurance only covers the pump up to a certain dollar value. The fancier pumps, you have to pay for, but I think you get a rebate from insurance. So a $200 pump is probably free, but this $1000 pump, is probably still going to cost you $800.

I'm guessing that that would require FDA approval, making it unattractive as the initial market.

If you read the article, you'd see that the pump in question already has FDA approval.

They have FDA approval. It’s stated in the first paragraph of the article.