Beta Bionics Gets Clearance for iLet Bionic Pancreas for Type 1 Diabetes

Beta Bionics’ iLet Bionic Pancreas has received FDA 510(k) clearance for its automated insulin delivery system for Type 1 diabetes.

The device does not require carb counting and fully automated 100 percent of all user insulin doses, the company said, “which means no calculations, less input, and less burden for the user as it 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.”

Paired with the Dexcom G6 glucose monitoring system, the only input needed is the patient’s weight, with no need to calculate carbs.

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