Bionic pancreas cleared for patients with type 1 diabetes

The FDA has cleared a new automated insulin dosing system, the agency announced on May 19.

The Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software, along with a compatible FDA-cleared integrated continuous glucose monitor, will form a new system called the iLet Bionic Pancreas. It is intended for use in patients ages 6 years and older with type 1 diabetes.

The system uses an adaptive closed-loop algorithm to determine and command insulin delivery. The algorithm is initialized only with a user's body weight and replaces conventional carbohydrate counting with a meal announcement feature, in which users estimate the amount of carbs in their meal as small, medium, or large, and the algorithm learns over time to respond to individual insulin needs.