Embecta Corp. has received FDA 510(k) clearance for its innovative tubeless insulin patch pump designed for managing type 1 and type 2 diabetes in adults. This clearance marks a significant advancement in insulin delivery technology, offering a new option for individuals requiring daily insulin management.
The disposable insulin delivery system includes a tubeless patch pump with a 300U insulin reservoir, designed to provide adjustable basal and bolus insulin for up to three days. The system also incorporates a locked-down controller featuring Bluetooth wireless technology and a color touchscreen, enhancing user experience and convenience.
Design and Development
The design of the system was influenced by feedback from individuals with type 2 diabetes and healthcare providers. A study sponsored by Embecta indicated that the 300U insulin reservoir would meet the three-day insulin needs of approximately 64% of people with type 2 diabetes, compared to a 200U reservoir meeting the needs of only 38% of the same population. This highlights the importance of reservoir capacity in meeting the needs of a diverse patient population.
Company Statement
"FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching Embecta as an independent company," said Dev Kurdikar, CEO of Embecta. "Achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes. This platform is also serving as the basis for an automated insulin delivery system in development."
Future Development
Embecta plans to submit a closed-loop version of its system, complete with an insulin dosing algorithm, to the FDA in the future. This advancement aims to further automate and optimize insulin delivery, potentially improving glycemic control and reducing the burden of diabetes management for patients.
