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News From the Food and Drug Administration
November 15, 2016

“Artificial Pancreas” Is Approved

JAMA. 2016;316(19):1957. doi:10.1001/jama.2016.16344

A new device that automatically monitors blood glucose levels and adjusts insulin levels has received FDA approval. The device, manufactured by Dublin-based Medtronic PLC, is the first such system to gain the agency’s blessing.

The new MiniMed 670G hybrid closed-loop system is intended for people aged 14 years or older who have type 1 diabetes. Because it operates with a smart algorithm that learns an individual’s insulin needs and delivers appropriate basal doses 24 hours a day, little user input is required. Patients who use the system will only have to enter their mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.

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