Medtronic Seeks Expanded Indication for Glucose Sensor

July 23, 2019

Medtronic has filed a premarket approval (PMA) submission with the FDA in an attempt to earn Medicare coverage for its Guardian Sensor 3, a device used to control insulin dosing.

The devicemaker said that it’s pursuing non-adjunctive labeling for the glucose monitor for use with its MiniMed 670 G — an insulin pump system — in order to get sensor reimbursement under Medicare.

“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,” the company said.

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