FDA approves Medtronic MiniMed 780G System for modifications

The FDA announced it has approved the MiniMed 780G System for modifications to the SmartGuard Technology and for expanding the indications for use to include the Guardian 4 Sensor. "The MiniMed 780G system is intended for continuous delivery of basal insulin (background insulin) at selectable rates, and the administration of insulin boluses (a single large dose of medicine) at a selectable amount for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SG technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. Compared to previously approved Medtronic automated insulin dosing systems, the MiniMed 780G System includes the new Advanced Hybrid Closed Loop algorithm as a part of its SG technology, which can issue automatic correction insulin boluses without user input. Additionally, the MiniMed 780G System offers multiple glucose targets as compared to a single glucose target in the MiniMed 670G/770G Systems," the FDA notice stated. Reference Link