The US Food and Drug Administration asked researchers working on the next generation artificial pancreatic device for diabetes patients to speed up the delivery of the device but said that the device makers will have to abide by the new set of guidelines for its approval in the United States.
Researchers are working on an artificial pancreas that will do away with the need to continuously monitor blood sugar levels for Type 1 diabetic patients. The device works by monitoring the glucose levels in the blood and injecting the right amount of insulin needed to bring the glucose levels back into normal range.
AdvertisementWhile the device is being eagerly awaited by diabetic patients across the globe, including more than 3 million Americans, diabetes groups in the United States feared that FDA's new set of guidelines would further delay the availability of the device in the country.
However the FDA has issued a statement saying that the agency will provide maximum flexibility to the manufacturers of the device but also added that the device will go through stringent review to make sure that it is safe.
"We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works", FDA's Center for Devices and Radiological Health director, Dr Jeffrey Shuren said.