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www.fdanews.com/articles/169515-tandem-diabetes-care-gets-fda-go-ahead-for-large-capacity-insulin-pump

Tandem Diabetes Care Gets FDA Go-Ahead for Large-Capacity Insulin Pump

January 13, 2015

Tandem Diabetes Care plans to launch its large-capacity t:flex insulin pump in the second quarter of this year, following the device’s clearance by the FDA. At 480 units, t:flex will be the largest pump available in the U.S., the company said Monday.

People with diabetes require varying amounts of daily insulin, depending on their level of insulin sensitivity. Teens with type 1 diabetes and many people with type 2 diabetes may need more than 100 units of U-100 insulin a day. According to San Diego-based Tandem, t:flex meets those needs and frees users from the need to make frequent reservoir changes necessary with 200- and 300-unit capacity pumps.

The pump integrates the slim design, delivery technology and touch-screen interface of Tandem’s popular t:slim pump. The company recognized that one size doesn’t fit all, said President and CEO Kim Blickenstaff, and t:flex was developed “to bring t:slim's benefits to people with greater insulin needs,” she added.

This is the first expansion of the company’s product portfolio and reflects its commitment to delivering user-friendly products that address unmet needs, Blickenstaff said. — Kellen Owings