Medtronic Solicits the US FDA for Non-Adjunctive Labeling Approval of MiniMed 670G Insulin Pump Sensor

Medtronic Solicits the US FDA for Non-Adjunctive Labeling Approval of MiniMed 670G Insulin Pump Sensor

Shots:

  • Medtronic has files PMA to the US FDA requesting approval for non-adjunctive labeling for its Guardian Sensor 3, as part of the MiniMed 670G closed-loop insulin pump system. Post-approval, the non-adjunctive status shows that the sensor is accurate to calculate insulin dose for meals and to correct high glucose levels
  • The PMA submission for non-adjunctive approval follows the launch of Guardian Link 3 transmitter which improved patients access by reducing the number of system alarms by 60% and utilizing SmartGuard technology in auto mode
  • The SmartGuard technology in the MiniMed 670G system personalizes the delivery of basal insulin 24 hrs./day and proactively drives increased Time in Range by consistently guiding to the target of 120 mg/dL in a day

Click here to read full press release/ article | Ref: Medtronics | Image: Medtronics