This is the second system to receive iAGC designation by the FDA, following the Company’s clearance of the t:slim X2 insulin pump with Control-IQ technology in December 2019
Image: Tandem Diabetes Care announces FDA Designation of Basal-IQ Technology as an interoperable automated glycemic controller. (Credit: Pixabay/Myriam Zilles)
Tandem Diabetes Care, a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance of its Basal-IQ technology as an interoperable automated glycemic controller (iAGC). This is the second system to receive iAGC designation by the FDA, following the Company’s clearance of the t:slim X2 insulin pump with Control-IQ technology in December 2019.
The FDA has classified three categories for the interoperability of devices as a complete automated insulin dosing (AID) system, which include an alternate controller-enabled insulin pump (ACE pump), an integrated continuous glucose monitor (iCGM) and an iAGC. The t:slim X2 insulin pump was also the first to receive an ACE infusion pump classification in February 2019, and the first insulin pump designated as compatible with iCGM devices in June 2018.
“Aligning Basal-IQ technology with Control-IQ technology under the FDA’s new regulatory path helps streamline our internal processes and provides us with a consistent approach to making future product enhancements,” said John Sheridan, president and chief executive officer. “Customer choice is a core tenet of our Company and this clearance supports our commitment to the interoperability of our AID technologies with our current and future insulin pump offerings.”
Source: Company Press Release