'Bionic Pancreas' Approved by FDA

  1. A closed-loop insulin delivery system, combining a continuous glucose monitoring device with an insulin pump, was approved for U.S. marketing Wednesday, the FDA announced.
    The approved Medtronic device is indicated for patients 14 years old and up with type 1 diabetes requiring at least 8 units of insulin daily. Medtronic is testing the system in children 7-13 years old in hopes of securing approval for this age group as well.

    "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," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in a statement announcing the decision.

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