I’ve previously mentioned the Medtrum patch pump which received TGA approval for supply in Australia in February 2018, although we don’t yet know if anyone’s going to actually bring this to market. The pump is part of the A6 TouchCare System. Medtrum have a standalone “S6” CGM, and standalone “P6” patch pump, and the A6 system integrates these into a linked system.
In the last few weeks we’ve seen some activity from Medtrum in the UK, starting to supply the pump and CGM through the National Health Service. See this tweet from Medtrum UK.
Just to clarify for my Australian readers, the TGA approval (entry on the ARTG: Australian Register of Therapeutic Devices) that was granted for the “A6 TouchCare System” specifically excludes the CGM component. To quote an except of the entry:
[…] medical devices identified by the manufacturer as Insulin Management System (Model code MD-SY-011) that contains the following three components: Personal Diabetes Manager (Model code MD-FM-011), Pump Base (Model code MD-JN-012), Reservoir patch (Model code MD-JN-011) (Qty 10) And User Guide (UG882011AU) and Label (LB882011AU) 2. Glucose sensors are not part of this Insulin Management System, i.e. are not to be supplied under this ARTG entry.
So just the patch pump and its “PDM” controller.
It is possible that the CGM may be imported in the future, but some further paperwork would need to be done with the TGA. But for now we just have to wait and see what happens.
At this point it does seem likely that there will be some more “new” devices (new for Australia at least) appearing later in 2018, including some aimed at the T2D market. But time will tell!