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FDA Approves New Guardian Sensor 3 Arm Indication

Medtronic news release; 2018 Feb 26

Medtronic plc has announced that the US Food and Drug Administration (FDA) has approved a new arm indication for the Guardian Sensor 3. The Guardian Sensor 3 is Medtronic's newest and most accurate continuous glucose monitoring device to-date and is the only sensor FDA approved to control automated insulin delivery via a hybrid closed loop system, the MiniMed 670G system.

This expanded indication will enable patients to wear the sensor on the upper arm, delivering more flexibility and enhanced performance for users, as well as improved accuracy, with a MARD of 8.7% following typical calibration methods used with the MiniMed 670G system. The Guardian Sensor 3 is currently available in the US for use with the MiniMed 670G system, which is approved for people aged ≥14 years with type 1 diabetes. In the US, Medtronic plc is headquartered in Minneapolis.

Citation:

Medtronic receives FDA approval for new arm indication for Guardian Sensor 3—Further Enhancing the MiniMed 670G Hybrid Closed Loop Experience. [news release]. Minneapolis, MN: Medtronic plc. February 26, 2018. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&.... Accessed March 1, 2018.

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