FDA approves Tandem’s predictive insulin pump software

The U.S. Food and Drug Administration on Friday granted approval for Tandem Diabetes Care’s software program that uses readings from a continuous glucose monitor to predict and deliver corrective doses of insulin to patients using the company’s t:slim X2 insulin pump.

Tandem’s Control IQ algorithm is the first insulin dosing software approved under the FDA’s new “interoperability” approval pathway. This allows companies to develop components of so-called artificial pancreas systems that can be used with products sold by other companies that have gone through the same approval process.

“That’s a really big deal for the industry,” Tandem Chief Executive John Sheridan said in a phone interview.

https://www.reuters.com/article/us-tandem-diabetes/u-s-fda-approves-tandems-predictive-insulin-pump-software-idUSKBN1YH21P