Embecta, a prominent global diabetes care company, has been granted 510(k) certification by the U.S. Food and Drug Administration (FDA) for its latest disposable insulin delivery system. This system is intended for individuals with type 1 and type 2 diabetes and includes a tubeless patch device with a 300-unit insulin reservoir. The design responds to feedback from users with type 2 diabetes, who frequently require a greater quantity of insulin than conventional pumps can accommodate. The patch device is designed to deliver adjustable basal and bolus insulin for three days, a critical feature for administering insulin to individuals with elevated daily insulin requirements.
The system also includes a Bluetooth-enabled controller with a color touchscreen to enhance user experience. This clearance marks a significant milestone for Embecta, which is focused on advancing diabetes care through innovative solutions. According to Embecta CEO Dev Kurdikar, the new system reflects the company’s commitment to improving life for those with diabetes. Future plans for the patch pump include a closed-loop version with an insulin-dosing algorithm, aiming to further enhance diabetes management and innovation in the field.
