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Beta Bionics gains FDA clearance for prefilled insulin cartridge

June 23, 2023

US-based diabetes-focused medical technology company Beta Bionics has received FDA 510(k) clearance for the compatibility of the Fiasp Pumpcart prefilled insulin cartridge with the iLet automated insulin-delivery system.

The iLet is a bionic pancreas that fully automates 100% of all user insulin doses, providing users with the choice of three insulins, Novolog; Humalog; and Fiasp Pumpcart.

The device eases diabetes management in everyday life and almost eliminates the expertise that has been required in the past to set up and manage a traditional insulin pump. In May 2023, Beta Bionics was awarded FDA approval for the iLet device.

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