The FDA approved Medtronic plc's MDT MiniMed 780G system with the Guardian 4 sensor requiring no fingersticks while in SmartGuard technology.
The system is approved for users seven years old and above with type 1 diabetes.
The move marks the approval of the only meal detection technology system that automatically adjusts and corrects sugar levels every five minutes for basal (background) and bolus (mealtime) insulin needs.
The system provides insulin to help account for when users occasionally forget to bolus or underestimate the number of carbs in their meals.
Medtronic says the MiniMed 780G system features the lowest glucose target setting (as low as 100 mg/dL) in any automated insulin pump on the market and one that more closely mirrors the average glucose.
It's also the only pump with an infusion set that can be worn for up to 7 days, doubling wear time.
In the U.S. pivotal trial of the MiniMed 780G system, users experienced 75% Time in Range (blood sugar between 70-180 mg/dL), with an overall Time Below Range of 1.8%.
Wells Fargo analyst Larry Biegelsen upgraded Medtronic from Equal-Weight to Overweight, raising the price target from $77 to $100.
Price Action: MDT shares are up 4.16% at $89.29 on the last check Monday.
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