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Tandem Diabetes' automated insulin delivery system gets FDA approval

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Tandem Diabetes' automated insulin delivery system gets FDA approval

Tandem Diabetes Care Inc.'s system for automated insulin delivery was approved by the U.S. Food and Drug Administration, the first device of its kind that can be used with other diabetes devices.

Tandem's Diabetes Care Control-IQ Technology connects a controller, an insulin pump and a continuous glucose monitor — collectively called an automated insulin dosing system — allowing automatic adjustments of the insulin dose based on blood glucose readings and a history of insulin delivery.

The insulin dosing system was evaluated under the FDA's de novo premarket review pathway, which allows submission for regulatory approval of novel, low-to-moderate-risk devices of a new type. The agency also established criteria outlining requirements for device safety, effectiveness, reliability, device interoperability, cybersecurity and clinical relevance.

San Diego-based Tandem is a medical equipment company that develops products for patients with insulin-dependent diabetes. The company received an approval in February for the insulin pump t:slim X2, an interoperable pump that can securely communicate with compatible automated insulin dosing systems, continuous glucose monitors and other electronic devices used for diabetes management.