I do not know, but I am pretty sure the interoperable Medtronic pump will not be a completely new pump. They will simply have one of their already approved pumps retrofitted with a different radio (BLE) and different software that allows remote communication and control. None of that is a huge engineering undertaking - they probably already have it in the works. That “new-old” pump will need to get ACE (alternate controller enabled) designation from FDA. Quoting from the FDA announcement when ACE designation was approved for Tandem t:Slim X2:
The FDA reviewed interoperable t:Slim X2 pump performance data demonstrating that the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.
Note that there are no clinical trials or outcomes mentioned, it’s just a technical review. I have no doubts Medtronic will be able to get that ACE designation pretty easily.
I really wish this were the case. They could just take 523/723 pumps and retrofit them with BLE, so we could ditch RileyLinks and use Loop with simple, proven in-warranty pumps. Unfortunately, I suspect the Medtronic ACE pump will likely be based on their newer style (such as 670g). We do not really know, maybe they surprise us all and come out with a BLE enabled ACE-designated 523/723 - I’d love that.