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FDA marketing clearance granted for high capacity pump
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The FDA has granted company clearance to Tandem Diabetes Care, Inc., to market the t:flex Insulin Pump, according to a company press release.
The pump, which is expected to launch in the United States in the second quarter of 2015, will have the largest insulin reservoir currently available at 480 units.
“In recognizing that one size does not fit all, the t:flex Pump was developed using Tandem’s proprietary technology platform to bring t:slim’s benefits to people with greater insulin needs,” Kim Blickenstaff, president and CEO of Tandem Diabetes Care, said in the release. “This first expansion of our product portfolio reflects our ongoing commitment to deliver user-friendly products that address unmet needs in the diabetes community.”
The pump is specifically designed for patients who require more than 100 units of U-100 insulin per day, such as adolescents with type 1 diabetes and many people with type 2 diabetes. The large capacity will allow for fewer reservoir changes.