This is a quote from the FDA 510(k) application (cleared 29 Aug 2013):
The OmniPod Insulin Management System is a tubeless insulin pump and is intended for intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. This system is comprised of two primary components, the insulin pump (pod) and the remote controller (Personal Diabetes Manager). The proposed device is a modification to the OmniPod Insulin Management System that removes the integrated blood glucose meter from the Personal Diabetes Manager.
What are they up to?? Making a PDM with no BG meter is lame, so I doubt that is the end goal. Hopefully this is a modular approach so that a BG meter can be paired to the PDM (think Legos), then any approved BG meter company (no doubt someone not in my formulary) can build a meter that snaps into the PDM.
Does anyone know?[1124-K131294.pdf|attachment](upload://3wxLBtOXcNrk6MGp4rXQ3Iwnheh.pdf) (139 KB)