The U.S. Food and Drug Administration (FDA) has granted clearance to Beta Bionics Inc. for the company”™s Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for use by people ages six years and older with type 1 diabetes.
According to the agency, these two devices ”“ along with a compatible FDA-cleared integrated continuous glucose monitor ”“ will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing system uses an algorithm to determine and command insulin delivery.
“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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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.”
