For immediate release:

Today, the U.S. Food and Drug Administration approved the Beta Bionics iLet ACE Pump and iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, together with an FDA-compliant continuous glucose monitor (iCGM), will form a new system called iLet Bionic Pancreas. The new automated insulin dosing (AID) system uses an algorithm to identify and manage insulin delivery.

“Today’s action will provide the type 1 diabetes community with additional options and flexibility for diabetes management and may help expand the reach of AID technology,” said Jeff Shoren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to developing new device innovations that can improve the health and quality of life for people with chronic diseases that require daily maintenance such as diabetes through precision medicine approaches.”

More than 11% of Americans are diagnosed with diabetes, which impairs the body’s ability to properly make or use the blood glucose-regulating hormone insulin. Because the pancreas does not produce insulin in people with type 1 diabetes, they must constantly monitor their glucose levels throughout the day and receive insulin treatment with an injection with a syringe, insulin pen, or insulin pump to avoid developing hyperglycemia (high glucose levels). In addition, managing type 1 diabetes includes following a healthy eating plan and being physically active.

iLet Bionic Pancreas uses an adaptive closed-loop algorithm that is configured only with the user’s body weight and does not require additional insulin dosing parameters. This adaptive algorithm eliminates the need to manually adjust insulin pump therapy settings and variables as required with conventional pump therapy, and is easier to start than other available AID systems. The iLet also simplifies use at mealtime by replacing traditional carb counting with the new Meal Announcement feature. With the new feature, users can estimate the amount of carbohydrates in their meal as small, medium, or large and the algorithm learns over time to respond to users’ individual insulin needs.

The human pancreas naturally provides a low, continuous rate of insulin, known as basal or posterior insulin. In patients with type 1 diabetes, the body’s ability to produce insulin is affected. iLet Dosing Software independently determines and commands increases, decreases, maintenance or suspensions of all basal insulin doses and sets and orders correction doses of insulin based on input from the iCGM. It also independently sets and orders meal doses of insulin based on meal advertisements.

The Food and Drug Administration (FDA) has reviewed the iLet ACE pump and iLet dosing decision program through Path 510(k) Pre-Market Clearance. A 510(k) is a pre-marketing submission submitted to the FDA to prove that a new device is substantially equivalent to an original, legally marketed device.

The US Food and Drug Administration (FDA) has authorized iLet ACE Pump and iLet Dosing Decision Software to Beta Bionics Inc.

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The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, and nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.