Prefilled insulin cartridge gets FDA nod

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.

“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. Medical Device Network