The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system.
The approval covers all configurations of the device — insulin-only, glucagon-only, and bihormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution.
The iLet Bionic Pancreas System is a pocket-sized, wearable investigational medical device that is designed to autonomously control blood-sugar levels. The on-body wear is similar to that of an insulin pump. Unlike insulin pump therapy, however, the investigational system is designed such that users enter only their body weight for the iLet to initialize therapy. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.