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Tandem Diabetes Care Announces FDA Designation of Basal-IQ Technology as an Interoperable Automated Glycemic Controller
SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food
About this update from Tandem Diabetes Care, Inc.
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nTandem Diabetes Care, Inc. (NASDAQ: TNDM), 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.\n\n\nThe 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.\n\n\n“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.”\n\n\nAbout Basal-IQ Predictive Low Glucose Suspend Technology\n\n\nThe simple-to-use t:slim X2 insulin pump with Basal-IQ predictive low glucose suspend technology uses glucose values from an integrated Dexcom G6 continuous glucose monitor to predict and help prevent lows with zero fingersticks.1,2,3 Basal-IQ technology uses CGM values to help reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dL or if a CGM reading falls below 70 mg/dL. Insulin delivery resumes as soon as sensor glucose values begin to rise.\n\n\nAbout Tandem Diabetes Care, Inc. \n\n\nTandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commerci...