Glossary Term
Artificial Pancreas
Definition
An Artificial Pancreas is a medical device system designed to automate blood glucose control in individuals with diabetes. It typically integrates a continuous glucose monitor (CGM), an insulin pump, and an algorithm that adjusts insulin delivery in real time, mimicking the glucose-regulating function of a healthy pancreas.
Relevance to the MedTech Industry
The Artificial Pancreas represents a significant advancement in diabetes management by reducing the burden of glucose monitoring and insulin dosing. It improves glycemic control, reduces the risk of hypoglycemia and hyperglycemia, and enhances quality of life for patients, driving innovation in the MedTech sector.
Additional Information & Related Terms
Continuous Glucose Monitor (CGM) A core component of the Artificial Pancreas system for real-time glucose monitoring.
Insulin Pump Delivers insulin as directed by the Artificial Pancreas algorithm.
Software as a Medical Device (SaMD) The control algorithm qualifies as SaMD and requires regulatory approval.
Clinical Validation Ensures the system’s safety and effectiveness under real-world conditions.