Medtronic seeks expanded labeling for MiniMed 670G insulin pump sensor

Medtronic (MDT +0.3%) has filed an application with the FDA seeking approval for non-adjunctive labeling for its Guardian Sensor 3, part of the MiniMed 670G closed-loop insulin pump system.

Non-adjunctive status means that the sensor is accurate enough to safely and consistently calculate an insulin dose for meals and to correct high blood sugar levels.

Medicare requires non-adjunctive labeling for sensor reimbursement. The company says the labeling, if approved, will broaden patient access.

Adjunctive labeling means that the glucose value generated by the sensor cannot be used directly, but indicate that a finger stick may be needed to determine the precise level of blood sugar.

https://seekingalpha.com/news/3480162-medtronic-seeks-expanded-labeling-minimed-670g-insulin-pump-sensor