Medtronic bids for expanded FDA indication for Guardian Sensor 3

Medtronic (NYSE:MDT) said it asked the FDA for an expanded indication for its Guardian Sensor 3 device that would open the glucose sensor up for Medicare reimbursement.

The Fridley, Minn.-based medtech titan said it filed for pre-market approval of non-adjunctive labeling for Guardian Sensor 3 for use with its MiniMed 670G insulin management system. If granted, the PMA would indicate that the device is accurate enough to calculate meal-based insulin doses and correct high glucose levels, Medtronic said.

“We are very proud of the clinical outcomes our MiniMed 670G system is delivering to patients on our system and we’re very pleased to see these results sustained in the real-world where many factors put the system to the test,” diabetes CMO Dr. Robert Vigersky said in prepared remarks. “Our goal now is improving usability and the overall patient experience with the system by increasing automation, and seeking expanded access to seniors covered under Medicare plans.”