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FDA Approves Medtronic’s MiniMed 780G Insulin Pump

Medtronic has finally received clearance (two years following its submission) for the latest version of their insulin pump technology by the FDA. It has also been three years since it was initially made available in Europe. Now the agency has signed off, they can begin distribution of their MiniMed 780G system within the US.

The FDA announced their approval late last Friday, and it allows those with Type 1 diabetes (as long as they are over 7 years old) to use the algorithmically-equipped diabetes management system, which is a combination of the Medtronic’s MiniMed pump along with its Guardian 4 continuous glucose monitoring sensor, as well as the company’s SmartGuard tech for automated insulin adjustments.
The Guardian 4 and MiniMed pump can both be used for up to 7 days before needing a hardware swap, and the company recently launched an infusion set for the latter, boasting double the standard life-span of alternative insulin pump tubing. Pre-orders for the system with be available from 15th of May, with the first shipments of the 780G expected to start “later in the summer”, and free software upgrades will be available for uses of the 770G system.

The latest MiniMed system is also equipped with the latest upgrade of Medtronic’s SmartGuard tech. If used in “Auto Mode”, earlier versions of the algorithm will take in blood sugar readings from the Guardian transmitter/sensor, and the every 5 minutes will automatically adjust the basal insulin dose of any connected MiniMed pump (or, if necessary, completely pause the delivery of insulin), to keep customers within a healthy glucose range. “Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes, and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections,” Que Dallara, president of the company’s diabetes division, said in the announcement. “A lot can happen to blood sugars in the span of an hour or even just a few minutes, so we’ve designed our system for real life—the algorithm adapts to the user and helps compensate for everyday challenges that are quite common around mealtimes,” Dallara said. “We built in features informed by extensive customer feedback, and we’re excited to deliver a system with ease of use at the forefront.”

© Medtronic Plc

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