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Breaking News: Simplera CGM Receives European Approval, Awaits FDA Nod

Simplera CGM

Innovative Simplera CGM, Granted European Approval

Medtronic, a pioneer in diabetes management, has successfully secured European approval for its revolutionary Continuous Glucose Monitor (CGM), Simplera. While the device awaits the green light from the U.S. Food and Drug Administration (FDA), the European approval paves the way for a significant leap in CGM technology. Fill out this form to see if you or a friend qualify for Continuous Glucose Monitors.

Enhanced Monitoring for All Ages

Simplera CGM is designed to benefit individuals with diabetes aged 2 and above. This groundbreaking device represents a substantial upgrade from the Guardian 4 sensor, offering remarkable features. Its sleek, disposable design eliminates the need for fingerstick calibrations and introduces a streamlined two-step insertion process, reducing the potential for errors.

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Innovative Design and Functionality

Simplera boasts a compact, flat design that resembles the aesthetics of the Dexcom G7 and Freestyle Libre 3 CGMs. Its key features include:

Smaller Size: Simplera is half the size of its predecessor, the Guardian 4 sensor, and boasts a flat, square sensor that can be comfortably worn on the back of the upper arm.

No Fingersticks: Users can bid farewell to fingerstick calibrations, as Simplera requires none. After a mere two-hour warm-up period, the device is ready to provide continuous glucose monitoring.

Simple, Two-Step Insertion Process: Unlike the Guardian 4, Simplera places the sensor in the center of the device, ensuring an easier and more accurate insertion process.

All-in-One Disposable Device: Simplera marks Medtronic’s first fully disposable CGM, integrating both the sensor and transmitter into a single device for user convenience.

No Overtape Required: The device’s adhesive is engineered with anti-lint materials to shield the sensor from sweat and water, eliminating the need for additional overtape.

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Preserving Proven Features

Medtronic has retained some of the trusted features of the Guardian 4 for Simplera, such as the two-hour warm-up time and a seven-day sensor lifespan. This seven-day lifespan suits those who prefer a routine, like changing their sensor every Sunday morning.

Integration with InPen and Smart Devices

Simplera seamlessly integrates with the InPen smart insulin pen, offering personalized dosing guidance for individuals who rely on multiple daily injections of insulin. This collaboration, facilitated by the InPen app, includes a bolus calculator based on carb ratios, meal estimations, insulin levels, and fixed dosing regimens. Together, Simplera and InPen form Medtronic’s Smart MDI system.

Universal Compatibility

Simplera is compatible with both Apple iOS and Android devices, including notifications on the Apple Watch, ensuring that users can access their glucose data easily.

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The Future: Integrating Simplera CGM with MiniMed 780G

Ali Dianaty, Medtronic’s Senior Vice President of Product Innovation and Operations, has expressed Medtronic’s commitment to further integrating Simplera CGM with the MiniMed 780G. The integration of Simplera with Medtronic’s MiniMed 780G Artificial Pancreas System is currently under regulatory review in Europe.

The clinical trial for MiniMed 780G with Simplera has completed its recruitment phase and is anticipated to conclude in December 2023. The data from this pivotal trial will play a crucial role in obtaining approvals for Simplera CGM in both Europe and the United States. Stay tuned for more updates on this exciting development in diabetes management technology.