Promising news for millions of Americans living with type 1 diabetes: The FDA has issued guidelines specific to developing an artificial pancreas — a system that would serve to continuously monitor blood glucose levels and deliver the correct amount of insulin to the body when needed, functioning just like a normal pancreas.
An early version of an artificial pancreas device is already sold in 50 countries — but not the United States. According to the FDA, these recently released draft guidelines are designed to provide medical device makers with clear guidelines that will facilitate the approval or an artificial pancreas device for patients in the U.S. The hope is that such a system would eliminate problems that arise with manually injecting insulin or infusion pumps .
"There are no systems on the market now that dose insulin automatically. This is an opportunity to get the U.S. back in line with the rest of the world and really pave the road to improve patient outcomes," said Aaron Kowalski, lead researcher at the Juvenile Diabetes Research Foundation.
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