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FDA Clears New Insulin Pump & Algorithm-Based Software for Type 1 Diabetes
FDA clears Beta Bionics iLet ACE Pump & iLet Dosing Decision Software for people with type 1 diabetes.
The U.S. Food and Drug Administration (FDA) has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people with type 1 diabetes. These two devices, along with an FDA-cleared integrated continuous glucose monitor (iCGM), will form the iLet Bionic Pancreas, an automated insulin dosing (AID) system that uses an algorithm to determine and command insulin delivery.
The iLet Bionic Pancreas simplifies use at mealtime by replacing conventional carb counting with a new meal announcement feature, and removes the need for manually adjusting insulin pump therapy settings and variables.
The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases like diabetes.
