regulatory
confidence high
sentiment positive
materiality 0.60
Tandem Diabetes receives FDA 510(k) clearance for SteadiSet infusion set for 7-day use
TANDEM DIABETES CARE INC
- FDA cleared SteadiSet infusion set for up to seven days of use; features integrated inserter with hidden needle.
- SteadiSet designed for type 1 diabetes patients; will be standalone for t:slim X2 and Tandem Mobi pumps.
- Also component of future Tandem Mobi tubeless insulin delivery system; manufacturing scale-up underway.
- Company expects to launch after scale-up; financial details in future earnings announcements.
item 8.01