Beta Bionics granted FDA Breakthrough Device Designation for iLet Bionic Pancreas System

Today Beta Bionics was granted FDA breakthrough device designation for the iLet bionic pancreas system. The designation was granted in all configurations of the iLet (insulin-only, glucagon-only and bihormonal). The meaning ofFDA breakthrough device designation is to provide patients and health care providers with timely access to medical devices byspeeding up their development, assessment, and review. This is amazing news for people with type 1 diabetes.

The iLet is the world’s first bionic pancreas system that autonomously controls blood sugar in people with type 1 diabetes as well as other conditions. Read full article here!


I’m a type 1 diabetic with diabetes knowledge in t1d and t2d, as well as nutrition and low-carb keto diet information, fitness and exercise programs to help keep you in optimal diabetes health. Take advantage of our diabetic health toolsfor a healthier lifestyle!

Diabetes Knowledge