U.S. approves first artificial pancreas system for diabetics
(Reuters) - The U.S. Food and Drug Administration has approved the first artificial pancreas system for diabetics that reads blood sugar levels and automatically shuts off the flow of insulin.
The device, made by Medtronic Inc, could help the 3 million Americans living with type 1 diabetes better manage their disease, which causes the immune system to destroy cells in the pancreas that make insulin.
Patients suffering from type 1 diabetes, the inherited version of the disease, have to regularly monitor their blood sugar levels and take insulin several times a day.
Too little or too much of insulin can lead to several health problems, ranging from kidney failure and heart disease to brain damage.
The device includes an insulin pump and a glucose sensor that stops insulin delivery when blood glucose reaches a preset level.
The system has been approved for use by diabetics aged 16 years and older. Medtronic said it would conduct a post-approval study that would include children aged 2 years and older.
The Minneapolis, Minnesota-based company said it would begin ramping up production immediately to prepare for a launch in the next few weeks.
The company will also directly follow up with patients and make certain manufacturing changes according to the requirements of the approval and an accompanying warning letter it was issued on September 19.
Medtronic said it has already addressed many of the observations in the warning letter and was committed to resolving the remaining issues as quickly as possible.
(Reporting by Esha Dey and additional reporting by Natalie Grover in Bangalore; Editing by Kirti Pandey)