Medtronic has secured approval from the US Food and Drug Administration (FDA) for its MiniMed 670G hybrid closed loop insulin delivery system to treat people with type 1 diabetes aged 14 years and older.
The company is also carrying out studies to expand the indication to additional patient populations.
The system features an advanced Guardian glucose sensor, which is approved by the FDA to control a hybrid closed loop system.
Guardian glucose sensor integrates diagnostic technology that continuously monitors sensor health.
With the support of SmartGuard HCL algorithm, the system can deliver a variable rate of insulin throughout the day based on the personalized needs of the patient.
The company plans to commercialize the MiniMed 630G system in the spring of 2017, while the regulatory approval outside the US is expected to be received in the summer of the same year.
Medtronic diabetes group chief medical officer Dr Francine Kaufman said: "The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes.
"We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease.”
Image: Medtronic’s MiniMed 670G hybrid closed loop insulin delivery system. Photo: courtesy of Medtronic plc.