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  • FDA approval of the iLet Bionic Pancreas.- Beta Bi...

FDA approval of the iLet Bionic Pancreas.- Beta Bionics

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Published:28th May 2023

Beta 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.

Sean Saint, President and CEO of Beta Bionics said “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.”

Condition: Diabetes Type 1
Type: drug

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