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Medtronic Receives FDA Approval for New Arm Indication for Guardian(TM) Sensor
Feb. 26, 2018 08:45AM PST
Medical Device Investing
Medtronic (NYSE:MDT), the global leader in medical technology, announced that the U.S. Food and Drug Administration (FDA) has approved a new arm indication for the Guardian(TM) Sensor 3. This expanded indication will enable patients to wear the sensor on the upper arm – delivering more flexibility and enhanced performance for users, as well as improved …
Medtronic (NYSE:MDT), the global leader in medical technology, announced that the U.S. Food and Drug Administration (FDA) has approved a new arm indication for the Guardian(TM) Sensor 3. This expanded indication will enable patients to wear the sensor on the upper arm – delivering more flexibility and enhanced performance for users, as well as improved accuracy, with a MARD of 8.7 percent following typical calibration methods used with the MiniMed(TM) 670G system.
As quoted in the press release:
“The performance of the Guardian Sensor 3 has been extremely impressive and this new arm indication now offers added convenience and flexibility for my patients who like to have as many options as possible to address their personal needs,” said Bruce Bode, M.D., FACE, a specialist with Atlanta Diabetes Associates and a clinical associate professor at Emory University. “These continued enhancements demonstrate a keen focus on the part of Medtronic to deliver a positive patient experience in addition to optimizing outcomes through technological advancements – that can prove to be just as meaningful for quality of life.”
