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FDA Grants Clearance to Beta Bionics for Prefilled Insulin Cartridge Compatibility with the iLet Bionic Pancreas

Friday, June 23, 2023

Beta Bionics, Inc., a prominent medical technology company specializing in diabetes, has recently announced that it has received FDA 510(k) clearance for integrating Fiasp® Pumpcart® prefilled insulin cartridges with their iLet Bionic Pancreas. The iLet Bionic Pancreas stands as a groundbreaking automated insulin delivery system that eliminates the need for carbohydrate counting and completely automates all user insulin doses. It now offers users the flexibility to select from three insulin options: Novolog®, Humalog®, and the newly added Fiasp® Pumpcart®.

Sean Saint, the President and CEO of Beta Bionics, expressed their dedication to creating an insulin delivery system that reduces the burden and enhances convenience for the type 1 diabetes community. Since its launch in May 2023, the iLet Bionic Pancreas has become available to clinics and users, who are undergoing training to familiarize themselves with its user-friendly design and effortless management features. By introducing Fiasp® Pumpcart® prefilled cartridges, users will save time by eliminating the manual cartridge filling process and will gain more choices for managing their diabetes effectively.

The iLet Bionic Pancreas was specifically engineered to simplify the daily management of diabetes and eliminate the extensive expertise typically required to operate a traditional insulin pump. Users only need to provide their weight as input to set up and manage the iLet Bionic Pancreas. It eliminates the need for carbohydrate counting, bolusing, correction factors, insulin-to-carbohydrate ratios, or pre-set basal rates. The iLet efficiently regulates glucose levels upon receiving a meal announcement, taking care of the rest of the work. Paired with the Dexcom G6 Continuous Glucose Monitoring System, the iLet ensures accurate glucose readings for optimal diabetes management.

https://www.betabionics.com/beta-bionics-announces-fda-clearance-for-the-use-of-a-prefilled-insulin-cartridge-with-the-ilet-bionic-pancreas/

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