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.

The iLet manages glucose levels with just a meal announcement and is paired with a Dexcom G6 Continuous Glucose Monitoring System for glucose readings.

All that is required for set-up is the user’s weight. While there is a need for carbohydrate awareness, no carb counting is necessary. Bolusing, correction factors, insulin-to-carb ratios, and pre-set basal rates are also unnecessary.

Beta Bionics president and CEO Sean Saint said: “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, the iLet bionic pancreas is now available and clinics and users are being trained on its simple design and easy management features.

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“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.”

According to a report by GlobalData, the insulin pumps and continuous glucose monitors market size was valued at $10.5bn in 2022.