Embecta Corp. has achieved a significant milestone in diabetes care with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its new disposable insulin-delivery system. This advanced system is designed to serve adults with both type 1 and type 2 diabetes, addressing a critical need in the market.
The system features a tubeless patch pump with a substantial 300-unit insulin reservoir, making it an ideal solution for individuals with type 2 diabetes who require higher daily insulin doses. This innovation fills a gap in current diabetes management tools, as the majority of automated insulin-delivery systems available today are primarily tailored for those with type 1 diabetes, despite type 2 diabetes accounting for approximately 90% of all diabetes cases.
Embecta’s new patch pump is a game-changer for those transitioning from multiple daily injections to pump therapy. With its larger insulin capacity, it offers a more practical and convenient option for managing diabetes. A recent study highlighted the efficacy of the 300-unit reservoir, revealing that it could meet the insulin needs of 64% of adults with type 2 diabetes over a three-day period, compared to only 38% using a 200-unit reservoir.
The fully disposable patch pump is designed to deliver both basal and bolus insulin for up to three days, providing users with a flexible and user-friendly experience. The system includes a locked-down controller featuring Bluetooth® wireless technology and a color touchscreen, further simplifying diabetes management.
Looking ahead, Embecta is planning to develop a closed-loop system that will incorporate an insulin-dosing algorithm. The company intends to pursue additional FDA submissions to expand its product line, continuing to enhance the options available for diabetes care.
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