CHICAGO (Reuters) – 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.
Reporting by Julie Steenhuysen; Editing by Bill Berkrot
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