FDA Approves Medtronic's Automated Insulin Delivery Device For Type 1 Diabetes

(RTTNews) - The U.S. Food and Drug Administration or FDA on Thursday announced that it approved Medical technology and services company Medtronic plc.'s (MDT) MiniMed 670G hybrid closed looped system. It is the first FDA-approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.

The MiniMed 670G hybrid closed looped system, often referred to as an "artificial pancreas," is intended to adjust insulin levels with little or no input from the user. It measures glucose levels every five minutes and automatically administering or withholding insulin.

While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said, "The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases - especially those that require day-to-day maintenance and ongoing attention. This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin."

As part of this approval, the FDA is requiring a post-market study to better understand how the device performs in real-world settings.

While the device is being approved for use in people 14 years of age and older with type 1 diabetes, Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7-13 years old.