SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for its Simplera Sync™ sensor, marking a significant expansion of its continuous glucose monitoring (CGM) portfolio in the United States. The approval enables integration of the Simplera Sync™ sensor with the company’s flagship MiniMed™ 780G system, offering greater flexibility and convenience to people managing diabetes through advanced insulin delivery technology.
Strategic Advancement in Diabetes Care Technology
The new Simplera Sync™ sensor is a disposable, all-in-one CGM sensor designed for ease of use and enhanced patient comfort. With no requirement for fingersticks* or overtape and a streamlined two-step insertion process, the sensor simplifies diabetes management without compromising accuracy. The integration with the MiniMed™ 780G system enables patients to benefit from real-time, adaptive insulin delivery paired with more user-friendly hardware — a strategic move that reinforces Medtronic’s commitment to innovation and patient-centric design.
“Our MiniMed™ 780G system delivers advanced diabetes technology for so many around the world, and we're excited to continue evolving this experience with expanded CGM options —including our Simplera Sync™ sensor, which we look forward to bringing to people living with diabetes in the U.S.,” said Que Dallara, EVP and president of Medtronic Diabetes.
Enhanced Clinical Impact Through Automation and Intelligence
The MiniMed™ 780G system uses SmartGuard™ technology and a powerful adaptive algorithm that automatically adjusts and corrects† glucose levels every five minutes, 24 hours a day. Uniquely featuring Meal Detection™ technology‡, the system delivers corrective insulin even when users miss or underestimate meal boluses. This level of automation enables:
- Improved time-in-range performance, exceeding international targets of 70% with optimal settings
- Flexible glucose targets as low as 100 mg/dL
- A treat-to-target approach that mimics non-diabetic glucose control
Real-world global data supports the efficacy of the system, making it a best-in-class solution for consistent and proactive diabetes management.
Operational Convenience and Long-Term Value
In addition to improved glucose control, the MiniMed™ 780G system stands out with the option to use the world's only 7-day infusion set — reducing the frequency of infusion changes and minimizing the burden on users. This can result in up to 96% fewer injections compared to traditional multiple daily injection therapies, increasing compliance and quality of life.
The Simplera Sync™ sensor enhances this offering by:
- Streamlining CGM use with fewer maintenance steps
- Reducing user training time
- Supporting long-term adoption of advanced insulin pump therapy
Market Implications and Future Rollout
With this FDA approval, Medtronic strategically broadens its reach in the highly competitive U.S. diabetes technology market, targeting both new and existing users of the MiniMed™ 780G system who seek an elevated standard of care. A limited U.S. launch of the Simplera Sync™ sensor is scheduled for fall 2025, with broader availability expected thereafter.
Currently, the MiniMed™ 780G system is compatible with the Guardian™ 4 sensor, giving patients the flexibility to choose the CGM solution that best fits their needs.
Commitment to Innovation and Customer-Centric Design
For over four decades, Medtronic Diabetes has led the industry in pioneering diabetes technology. With an emphasis on sensor advancement, intelligent insulin delivery, and AI-powered decision support, the company continues to evolve its product offerings to meet the growing needs of a global patient population.
“We're committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day,” said Dallara.
To learn more about Medtronic Diabetes and its latest technologies, visit www.medtronicdiabetes.com.