Tandem Diabetes Care, Inc. (NASDAQ: TNDM) rose sharply after the company reported Food and Drug Administration approval of the t:slim X2 Insulin Pump with Basal-IQ technology.
The San Diego-based Tandem manufactures t:slim X2, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia).
This is the first automated insulin delivery system approved for use by children as young as six years old, and the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices.
The Company plans to launch its new product with Dexcom G6® continuous glucose monitoring (CGM) integration, which requires no fingersticks for calibration or diabetes treatment decisions and was the first CGM device to receive the iCGM designation from the FDA earlier this year Tandem expects the t:slim X2 Pump with Basal-IQ technology to be available in August 2018, and all in-warranty t:slim X2 users in the United States will have the option to add the new feature free of charge via remote software update.
CEO Kim Bickenstaff said "The t:slim X2 Pump with Basal-IQ technology was designed to predict and help prevent time spent low using best-in-class CGM technology.
"As the first company to launch a touchscreen insulin pump capable of remote feature updates, and now the first to have a pump approved with iCGM compatibility, we are delivering new innovation to our customers at a pace that is unprecedented in our industry, furthering our mission to help improve the lives of people with diabetes."
Shares galloped $4.51, or 22.2%, to $24.82 Friday morning.
