Medtronic Receives FDA Approval for Simplera Sync Sensor in MiniMed System 

In a significant development for diabetes care, Medtronic has announced U.S. FDA approval of its Simplera Sync™ sensor for use with the MiniMed™ 780G system, marking the debut of the world’s only automated insulin delivery system featuring a tubeless, disposable, and fully integrated continuous glucose monitor (CGM). 

The Simplera Sync sensor is a key innovation in Medtronic‘s CGM portfolio. Designed for simplicity and comfort, it features a two-step insertion process and eliminates the need for fingersticks and overtape. The sensor offers a seamless, user-friendly experience with its all-in-one, fully disposable design. 

“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. 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, in a statement. 

Also Read: Medtronic Partners with Methinks AI to Enhance Stroke Care 

What Sets Simplera Sync Apart 

Unlike conventional CGMs that often require reusable components or cumbersome insertions, Simplera Sync is disposable, requires no fingersticks, and is water-resistant. When paired with the MiniMed 780G, the sensor leverages an advanced algorithm that adjusts insulin delivery every five minutes, effectively maintaining glucose levels within target ranges with minimal manual intervention. 

The MiniMed 780G system, already a standout in automated insulin delivery, incorporates Meal Detection™ technology, enabling it to deliver extra insulin when glucose levels rise unexpectedly, such as after meals that were missed or undercounted. This feature is particularly valuable for individuals who struggle with carb counting or inconsistent eating schedules. 

Future Outlook 

While the system has been available in international markets, the newly approved Simplera Sync sensor is expected to reach U.S. consumers in a limited launch by Fall 2025. This phased rollout is intended to ensure a smooth distribution and training process for healthcare providers and patients. 

The FDA’s green light reinforces Medtronic’s leadership in diabetes technology, further positioning the company at the forefront of innovation in closed-loop insulin delivery systems. The approval comes as diabetes management continues to shift toward more personalized, data-driven, and automated solutions, an area where Medtronic is clearly investing for long-term impact. 

MedTech Malta 2025: Where Innovation Meets Impact 

Mark your calendars for 12–14 November 2025, as MedTech Malta returns to Valletta for three days of focused dialogue and meaningful exchange within the medical technology sector. This year’s event will bring together founders, investors, regulators, and professionals from across the industry for a programme centred on practical insights, informed discussions, and genuine opportunities to connect. Whether you’re aiming to pitch a startup, explore partnerships, understand regulatory shifts, or learn about developments in health tech, MedTech Malta offers a grounded setting for progress. The agenda includes moderated panels, curated networking sessions, and the return of the Startup Pitch Competition, highlighting early-stage ventures working on practical solutions. To get involved, reach out to [email protected]. Early bird tickets are now open—available for a limited time before prices increase.