Approvals

The US Food and Drug Administration (FDA) has announced that it has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people over the age of six with type 1 diabetes. The devices, along with a compatible and approved integrated continuous glucose monitor (iCGM), will form a system known as the iLet Bionic Pancreas.

The automated insulin dosing (AID) system will use an algorithm to decide and trigger insulin delivery. The algorithm removes the need for patients to manually adjust insulin pump therapy settings and variables, making it considerably easier to operate than other AID systems.

The FDA reviewed both the iLet ACE Pump and the iLet Dosing Decision Software through the 501(k) premarket clearance pathway, and granted approval to both.

Jeff Shuren MD JD, director of the FDA’s Center for Devices and Radiological Health (CDRH), commented: “Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology. The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes through precision medicine approaches.”