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Approval Granted by FDA for Simplera Sync Sensor Compatible with MiniMed 780G

Medtronic secures FDA approval for employing the Simplera Sync sensor in tandem with the MiniMed 780G system.

Approval granted for Simplera Sync sensor integration with MiniMed 780G insulin pump by the Food...
Approval granted for Simplera Sync sensor integration with MiniMed 780G insulin pump by the Food and Drug Administration

Approval Granted by FDA for Simplera Sync Sensor Compatible with MiniMed 780G

Medtronic Announces New Diabetes Company and Innovative Sensor for MiniMed 780G System

Medtronic, a global leader in medical technology, has announced the name of its planned new diabetes company – MiniMed. The company is set to launch its latest innovation, the Simplera Sync sensor, for the MiniMed 780G system.

The MiniMed 780G system, already a game-changer in diabetes management, will see an enhancement with the introduction of the Simplera Sync sensor. This sensor, approved by the FDA for use with the MiniMed 780G system, offers a 6-day wear time with an additional 24-hour grace period and is designed for easy application. It is approved for insertion only on the back of the upper arm for users aged 7 and older.

The MiniMed 780G system's adaptive algorithm adjusts glucose levels every 5 minutes, 24/7, using a "treat to target" approach and flexible glucose targets as low as 100 mg/dL. The system can be used with the Guardian 4 sensor, but the addition of the Simplera Sync sensor offers more flexibility.

The Simplera Sync sensor's continuous glucose monitoring is integrated seamlessly with the MiniMed 780G insulin pump. This integration supports improved diabetes management through automated insulin delivery adjustments. The sensor's design avoids sites with high motion or friction to maintain accuracy and minimize discomfort.

The specific site approval (back of the upper arm) and guidance to avoid areas near infusion or injection sites help reduce interference and optimize glucose sensing performance. The sensor also comes with sensor life indicators to alert the user when it is nearing expiration.

Global users consistently achieve time in range above international targets of 70% when using optimal settings with the MiniMed 780G system. The system works with an infusion set that lasts up to 7 days, reducing the number of injections compared to multiple daily injections.

Que Dallara, Medtronic's EVP and president of Medtronic Diabetes, stated the company's commitment to driving innovation for people living with diabetes. This commitment is evident in the FDA approval of the world's first adaptive deep brain stimulation system for people with Parkinson's, a testament to Medtronic's ongoing efforts in neuroscience research.

In summary, the Simplera Sync sensor enhances glycemic control in the MiniMed 780G system by offering reliable, user-friendly continuous glucose sensing with clear life-cycle indicators, targeted placement guidance for accuracy, and compatibility that supports automated pump insulin delivery for people with diabetes aged 7 and above. The limited launch of the Simplera Sync sensor will begin in the U.S. in the fall of 2025.

[1] Medtronic Press Release, [link to press release] [2] Medtronic Product Information, [link to product information]

The new Simplera Sync sensor, an innovative addition to Medtronic's MiniMed 780G system, is set to revolutionize digital health by offering advanced continuous glucose monitoring for people with diabetes. This sensor underscores Medtronic's commitment to science and medical-conditions, particularly health-and-wellness, as demonstrated by their ongoing research in neuroscience and advancements in medical technology.

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