Embecta Wins FDA Nod for Disposable Insulin Patch Pump

Embecta has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary, disposable insulin delivery system.
 
The device is indicated for adults who need insulin to manage diabetes, including both type 1 and type 2. The system has a tubeless patch pump design with a 300-unit insulin reservoir. This design, the company said, was informed by feedback from people with type 2 diabetes and their healthcare providers.
 
The wearable, fully disposable patch pump provides adjustable basal and bolus insulin for up to three days. Its 300-unit reservoir aims to accommodate people with higher daily insulin needs, which embecta said is typical for people with type 2 diabetes.
 
A recent embecta-sponsored study showed a 300-unit insulin reservoir would meet the needs of 64% of adults with type 2 diabetes for three-day wear, while a 200-unit reservoir would only meet the needs of 38% of that same population.
 
The system also features a locked-down controlled with Bluetooth wireless technology and a color touchscreen to simplify the interface and user experience.
 
The company said its patch pump development program includes plans for a closed-loop version, including an insulin-dosing algorithm in a future FDA submission.
 
“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,” said Dr. Colleen Riley, embecta’s chief technology officer. “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.”