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# Medtronic Seeks Non-Adjunctive Label for Insulin Sensor
- URL: https://www.fdaweb.com/medtronic-seeks-non-adjunctive-label-for-insulin-sensor/
- Published: 2019-07-23T12:00:00.000Z
- Updated: 2026-09-15T01:39:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144596

Medtronic has submitted a PMA for non-adjunctive labeling for its Guardian Sensor 3, which is part of the MiniMed 670G insulin delivery system. If the agency approves a sensor with non-adjunctive labeling, it means that a sensor is accurate enough to be used to calculate an insulin dose for meals and to correct high glucose levels, the company says. “Since Medicare requires a non-adjunctive label for sensor reimbursement, if approved, this labeling could broaden patient access by allowing for Medicare coverage of the world’s first and still the only commercially available hybrid closed loop system,” it says.

Medtronic says the MiniMed device is currently being used by more than 180,000 patients. The device’s SmartGuard technology is designed to automate and personalize insulin delivery 24 hours a day and it proactively drives increased “time in range” by guiding to the target of 120 mg/dL throughout the day, it says.