On April 21, the FDA announced approval of the MiniMed 780G System for modifications to the SmartGuard Technology and for expanding the indications for use to include the Guardian 4 Sensor.
The system is intended for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for the management of type 1 diabetes in patients ages 7 years and older requiring insulin. It is also intended to continuously monitor glucose values in the fluid under the skin.
The system includes SmartGuard Technology, which can be programmed to automatically adjust insulin delivery based on glucose values from continuous glucose monitoring sensors and can suspend delivery of insulin when the SmartGuard value falls below or is predicted to fall below predefined threshold values. Compared to previously approved Medtronic automated insulin dosing systems, the device includes a new algorithm that can issue automatic correction of insulin boluses without user input.
On April 27, the FDA also approved a modification to the system to enable the firmware's over-the-air update feature, which allows patients to receive firmware updates directly to their pump.