Beta Bionics Announces FDA Clearance of the iLet Bionic Pancreas

Previously Published on NewsWire.comBeta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance and the commercial launch of the iLet Bionic Pancreas. The iLet is the first and only automated insulin-delivery system that does not require carb counting and fully automates 100% of all user insulin doses – which means no calculations, less input, and less burden for the user. The iLet is paired with the Dexcom G6 Continuous Glucose Monitoring System.

Beta Bionics Announces FDA Clearance and Commercialization of the iLet Bionic Pancreas

“This company has worked tirelessly over the past seven years to bring the first Bionic Pancreas to market. And now the iLet is here, ready to be prescribed to the T1D community and will ship imminently,” said Sean Saint, President and CEO of Beta Bionics. “As the first fully-automated insulin dosing system, the iLet changes the paradigm of diabetes management. By eliminating traditional setup, carb counting, and manual correction boluses, the iLet has removed many of the traditional tasks for both the user and healthcare provider. We hope that, for many people, the iLet helps to make diabetes a little bit easier.”

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. With the iLet, healthcare providers can spend less time with the technology and more time with their patient. The only input that is required to get started is the user’s weight — the iLet does the rest. There is no longer the need to figure out the complexities of carb counting, bolusing, correction factors, insulin-to-carb ratios, or pre-set basal rates. iLet users enter their weight and then “GO BIONIC” with their diabetes management.

“The iLet’s unique algorithms autonomously personalize insulin dosing for each person’s unique needs,” explained Dr. Steven Russell, MD, PhD, Chief Medical Officer at Beta Bionics. “This degree of automation relieves healthcare providers from the burden of reviewing blood glucose and CGM data in order to adjust pump settings, allowing them to spend more time discussing other needs. There are so many people with diabetes with stubbornly high A1c and low time in range, despite adjustments to their therapy. Data from the Pivotal Trial suggests the iLet could make a big difference for those people.”

First and only, automated insulin-delivery system that determines 100% of all insulin doses. – No carb counting*, no corrections, no calculating boluses. – Only needs your body weight to get started.

Read the full article on


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!

Add Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Diabetes Knowledge