Beta Bionics has received approval from the US Food and Drug Administration (FDA) for its iLet ACE Pump and iLet Dosing Decision Software to treat people with type 1 diabetes aged six years and above.
The pump and the software, accompanied by a compatible integrated continuous glucose monitor (iCGM), are part of a new system called iLet Bionic Pancreas.
For determining and controlling insulin delivery, the new automated insulin dosing (AID) system deploys an algorithm.