Tandem Diabetes Care wins FDA clearance for Basal-IQ tech as interoperable automated glycemic controller
Summary
Tandem Diabetes Care (NSDQ:TNDM) this week announced that it won FDA clearance for its Basal-IQ technology for interoperable automated glycemic control (iAGC). The FDA has only classified three categories for the interoperability of devices as a complete automated insulin dosing (AID) system, an integrated continuous glucose monitoring and an iAGC. “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 enhancement,” president and CEO John Sheridan said. “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.” The t:slim X2 insulin pump with Basal-IQ predictive low glucose suspend technology uses glucose values from a Dexcom G6 continuous glucose monitor to predict and prevent low glucose levels without fingersticks. It predicts glucose levels 30 minutes ahead and stops insulin if they are expected to drop below 80mg/DL or if the CGM reading falls below 70 mg/dL.
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