Gregory's Server@djh Android APS is an open source/patient-and-advocate-driven project. So…no approval involved, really. There’s a very long history here that I (pump wearing T1D) don’t know all the details of about unbelievably frustrating FDA/regulatory foot dragging on approving innovations in closed loop pump technology. The most specific early precipitating example was probably European regulators approving the first Medtronic Guardian system something like five+ years before the US did.
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@djh (sorry, you didn’t really ask for a walk through recent socio-technical-regulatory history viz a viz type 1 diabetes medical equipment, but I felt like just saying “AAPS is open source” without at least SOME context was only gonna be more confusing…) |
@djh they’ve basically caught up (and in fact IMO have possibly swung a bit too hard), but it contributed to a trend of T1D-adjacent folks hacking the available technology to DIY their own closed loop pumps. I have the impression that the movement led to embarrassment at the FDA, amping the pressure to figure their shit out when it comes to approving pump software innovations (like official closed loop stuff, which has been an astonishing game changer in T1D management over the last <5 years).