FDA Approves Customizable Insulin Pump

The Tandem Diabetes Care t-Slim X2 insulin pump was approved by the U.S. Food and Drug Administration.

What’s so special? It’s the first customizable device. Considered an alternate controller enabled (ACE) infusion pump, or an interoperable pump, users can tailor their preferences with different components.

With this approval, the FDA is establishing “special controls” defining the requirements of ACE infusion pumps to ensure accuracy, reliability, and cybersecurity.

Image Source: Children’s Diabetes Foundation

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FDA Approves Customizable Insulin Pump

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