Medtronic Requests Approval of Non-Adjunctive Labeling from FDA
Medtronic plc. Ordinary Shares (MDT)
Last medtronic plc. ordinary shares earnings: 2/18 06:45 am
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Source: GlobeNewswire
DUBLIN, July 23, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE: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 be used to calculate an insulin dose for meals and to correct high glucose levels. 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. The MiniMed 670G system is being used by more than 180,000 people today1, and the associated data on nearly 8 million patient days2 shows an average Time in Range of 71% across all age groups, which mirror
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