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Beta Bionics wins FDA approval for new insulin pump

May 22, 2023

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.

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