A Revista Cadernos de Cultura e Ciência é de caráter nacional e multidisciplinar, cadastrada com o ISSN 1980-5861.

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U.S. FDA approves Tandem's predictive insulin pump software

por Ron Tomlinson (2020-06-17)

Li\u0026#39;l Kash Breast Pump Bag - Power Kate - BabymamaCHICAGO, Dec 13 (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)


ISSN: 1980-5861