MASSDEVICE ON CALL — Safety concerns by the FDA have stalled the development of an artificial pancreas to treat Type I diabetes.
Advocates of the artificial pancreas have been calling for the federal watchdog agency to issue a clear guidance for months and they could get an answer as early as this afternoon.
Yet supporters feel that cumbersome regulations by the federal watchdog agency requiring proof of safety and efficacy for low glucose suspend systems could set back U.S. approval for at least 2 1/2 years according to Reuters.
"The FDA wants the artificial pancreas on the market as much as anyone else does. We just have to operate within U.S. laws to make sure it is safe and effective," the FDA’s Charles Zimliki told the wire service earlier this year.
The Juvenile Diabetes Research Foundation unveiled a petition early last month, signed by more than 100,000 senators, doctors and patients, urging the FDA to issue swift and clear guidance for the development of an artificial pancreas for diabetics.
The petition, which was posted on the JDRF’s website Oct. 3, calls for the federal watchdog agency to issue a guidance that speeds up its recommended device development process, allowing short-term, in-hospital evaluations of artificial pancreas systems followed by outpatient trials of no more than three months long.
Medical device goliath Medtronic’s (NYSE:MDT) Paradigm Veo insulin pump is an early version of an artificial pancreas that’s sold in 50 countries outside the U.S.
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