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.