The t:slim X2 pump has been blocked from sale since December 2020 due to safety concerns raised through the TGA.
Today AMSL mailed their customers to let them know the suspension of the pump’s TGA registration is officially over. Apparently it was lifted a week ago, but neither the TGA nor AMSL were saying anything about it last week.
Existing users of the pump were able to continue, and get upgraded to the Basal-IQ software that uses the Dexcom G6 to implement low-glucose suspension to avoid hypos. But now the pump is also available for sale to new customers again.
The Control-IQ “full looping” software upgrade can’t be far away. It received TGA approval last November, and in the last few months AMSL has been busy training staff and DEs in preparation for its rollout.
Strange that we don’t know what the problem with the pump was, or why it has been allowed to go back on sale with no apparent modification. It appears that they are no longer allowed to sell the pump with the G5 software, which suggests that it is the battery issue associated with the G5 firmware version of the pump. Perhaps there is some slight change that we don’t know about in the firmware of the pumps that will be shipped from now on.
A bit more clarity and transparency would give more confidence!