Medtronic Gets FDA Approval for Upper Arm Glucose Monitoring
Minnesota-based medical device manufacturer Medtronic announced Monday that the Guardian Sensor 3, their continuous blood glucose monitor, had received FDA approval to be used on the upper arm as well as the abdomen. The device is designed to pair with an insulin pump. The combination of the two devices continuously measures blood glucose, administers medication as needed, and alerts patients when their glucose levels may be about to spike or drop, providing patients with a “set it and forget it” approach to blood glucose management.
For diabetics, the U.S. Food and Drug Administration is now allowing the Minnesota-run company to market its Guardian Sensor 3 to be worn on the upper arm. Previously the device was only recommended to be worn on the abdomen to measure the amount of insulin in a patient’s blood stream…
The Guardian Sensor 3 is approved for use with Medtronic’s popular MiniMed 670G insulin pump, which is the only insulin pump on the market that is allowed to automatically adjust the amount of medication it delivers based on readings from a glucose sensor. The pump is intended for people with type 1 diabetes who are at least 14 years old.
The company also announced that they had received regulatory clearance for the Resolute Onyx 2.0 mm, a new stent which is small enough to prop open small blood vessels closer to the heart.