Today comes word that Medtronic desperate to save their struggling CGM unit has asked the FDA for an non-adjunctive label for the Guardian™ Sensor 3. Per a company issued press release;
“ Medtronic plc (MDT), the global leader in medical technology, services and solutions, today announced its Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) requesting approval for non-adjunctive labeling for its Guardian™ Sensor 3, as part of the MiniMed™ 670G system. If the FDA approves a sensor with non-adjunctive labeling, it means that a sensor is accurate enough to . . .
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