[brandall10]

I recently worked for a company called Tandem Diabetes which has multiple closed loop, FDA-regulated systems going back 9 years:

"In July 2014, Tandem announced that it had submitted a PMA for the t:slim G4 insulin pump, which integrated t:slim Pump technology with the Dexcom G4 Platinum CGM System. This device was approved by the FDA in September 2015."

https://en.wikipedia.org/wiki/Tandem_Diabetes_Care

We were still working on international support when I left last year. As you can imagine, there are quite a few regulatory hurdles esp. regarding patient data portability and access.