Leading experts from industry, academia, and government came together in early April in Bethesda, MD, to discuss innovation in the development of an artificial pancreas at a workshop hosted by the National Institutes of Health, the Food and Drug Administration (FDA), and JDRF. Artificial pancreas systems will automate insulin delivery and likely other hormones in [...]
Leading experts from industry, academia, and government came together the second week of April in Bethesda, MD, to discuss innovation in the development of an artificial pancreas system at a workshop hosted by the National Institutes of Health, the Food and Drug Administration (FDA), and JDRF. A commercially-viable artificial pancreas system would mimic the biological [...]
The U.S. Food and Drug Administration (FDA) announced on November 9 the issuance of its final guidance for the development of artificial pancreas systems. The guidance incorporates nearly all of JDRF’s recommendations. This news represents a milestone victory for JDRF and the type 1 diabetes (T1D) community, as the technology is viewed by medical experts [...]
The JDRF Artificial Pancreas Project has significantly accelerated progress towards the delivery of the first artificial pancreas (AP) systems to people with diabetes. Research progress has been exceptional with multiple studies in controlled settings demonstrating that AP systems can significantly reduce high and low blood sugar levels automatically. For people with diabetes to realize the [...]
Because the simulator is now FDA-approved, the process of receiving regulatory approval for human trials of closed-loop systems will be faster and more clearly defined—a significant achievement that should also accelerate the development and possible commercialization of a closed-loop artificial pancreas.