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PARSIPPANY, N.J. – Embecta Corp. says it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary disposable insulin delivery system.
Indicated for adults who require insulin to manage diabetes, including both type 1 (T1D) and type 2 (T2D), the system includes a tubeless patch pump design with a 300-unit insulin reservoir that was informed by feedback from people with T2D and their healthcare providers.
“FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching embecta as an independent company, and achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes,” chief executive officer Dev Kurdikar says. “As we continue to advance toward our vision of a life unlimited by diabetes, our team has focused on developing a patch pump that could address some of the most significant obstacles to adopting pump therapy for people who use insulin daily to manage their diabetes. This platform is also serving as the basis for an automated insulin delivery system in development.”
The system includes a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days, depending on the needs of the user. The patch pump features a 300-unit insulin reservoir that accommodates people with higher daily insulin needs, which is typically true of people with type 2 diabetes. For such people, the on-market patch pumps may not hold enough insulin to meet their needs for three days. For example, a recent embecta-sponsored study showed that a 300-unit insulin reservoir would meet the needs of 64% of adults with T2D for three-day wear, while a 200-unit reservoir would only meet the needs of 38% of that same population.
In addition to the patch pump, the system comprises a locked-down controller featuring Bluetooth wireless technology with a color touchscreen designed to create a simplified interface and user experience.
“Our research and development, medical affairs and regulatory teams identified an unmet need within the diabetes community and shepherded this project from concept to clearance with dedication and diligence,” says chief technology officer Dr. Colleen Riley. “I want to thank the embecta team for their commitment to serving people with diabetes and thank the FDA for their timely review and clearance of a system that has the potential to reduce the burden of managing diabetes for more people and significantly move innovation in this area forward.”
Embecta, a global diabetes care company with a 100-year legacy in insulin delivery, says its patch pump development program also includes plans for a closed-loop version including an insulin-dosing algorithm in a future FDA submission.
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