FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery
Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.“Today’s action will provide theContinue…