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FDA Approves Medtronic’s Artificial Pancreas

October 1, 2016

The FDA has approved the first artificial pancreas, which automatically monitors glucose and provides the appropriate insulin dose.

Medtronic’s MiniMed 670G hybrid closed-loop system is indicated for patients with type 1 diabetes who are 14 years of age and older.

The device has a sensor that attaches to the body under the skin and an insulin pump that is strapped to the body. An infusion patch connects to the pump to deliver the basal insulin.

Medtronic is also conducting a pediatric study in patients ages 7 to 13.

Regulatory approval of the MiniMed 670G is expected outside of the U.S. in summer 2017.