Beta Bionics Announces FDA Clearance for the Use of a Prefilled Insulin Cartridge With the iLet Bionic Pancreas

iLet Dexcom G6

iLet with Dexcom G6

  • Now the iLet Bionic Pancreas is cleared for three insulins
  • More insulin choices for users
  • Prefilled insulin cartridge saves time and provides convenience for users

Beta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance for compatibility with the Fiasp® Pumpcart® (insulin aspart) prefilled insulin cartridge. The iLet is the first and only automated insulin-delivery system that does not require carb counting, fully automates 100% of all user insulin doses, and will provide users the choice of three insulins - Novolog®, Humalog® and Fiasp® Pumpcart®

"Beta Bionics has been working tirelessly to create an insulin delivery system that offers less burden and more convenience for the type 1 community. Since launching last month in May 2023, the iLet Bionic Pancreas is now available and clinics and users are being trained on its simple design and easy management features," said Sean Saint, President and CEO of Beta Bionics. "When Fiasp® Pumpcart® prefilled cartridges are available, users will save time not having to manually fill cartridges and will have more choice for their diabetes management."

The iLet was designed to alleviate the work of diabetes management in everyday life and nearly eliminate the expertise that has been required to set up and manage a traditional insulin pump. The only input that is required to get started is the user's weight. No carb counting*, bolusing, correction factors, insulin-to-carb ratios, or pre-set basal rates - the iLet manages a user's glucose levels with just a meal announcement and it does the rest of the work. The iLet is paired with a Dexcom G6 Continuous Glucose Monitoring System for glucose readings.

If you'd like to GO BIONIC with the iLet Bionic Pancreas, visit our website to fill out a form to get started -

*Carb awareness is required. 

Fiasp® Pumpcart®, Humalog® and Novolog® are registered trademarks of Novo Nordisk A/S. Fiasp® Pumpcart® not yet available for sale in the US. 

Contact Information:
Stephen Feider
Chief Financial Officer & Corporate Secretary
[email protected]

Karen Hynes
Vice President of Marketing
[email protected]

Original Source: Beta Bionics Announces FDA Clearance for the Use of a Prefilled Insulin Cartridge With the iLet Bionic Pancreas