Medtronic Diabetes Announces FDA Clearances, MiniMed Medicare Access

Medtronic announced three U.S. milestones that expand access, choice, and flexibility for people living with type 1 and insulin‑requiring type 2 diabetes. The benchmarks include Medicare access for the MiniMed 780G system paired with the Instinct sensor, made by Abbott, U.S. Food and Drug Administration (FDA) clearance for the system’s use with ultra rapid‑acting insulins, and clearance of the MiniMed 780G system for use with the Instinct sensor for insulin-requiring type 2 diabetes.

“These milestones reflect our commitment to expanding access and giving individuals living with diabetes more choice in how they manage their condition,” said Que Dallara, executive vice president and president, Medtronic Diabetes. “By broadening sensor and insulin options for the MiniMed 780G system, we’re empowering more people to benefit from automated insulin delivery that supports easier mealtimes, greater flexibility, and more confident diabetes management—making everyday life a bit easier.”

Medicare Access for MiniMed 780G System

Medicare and Medicare Advantage beneficiaries can now access the MiniMed 780G system with the Instinct sensor, made by Abbott. The Instinct sensor is small, thin, and worn discreetly, with up to 15 days of wear. Such availability expands sensor choice for Medicare users, who also have access to the Simplera Sync and Guardian 4 sensors.

Access to advanced technologies like the MiniMed 780G system can help reduce burden by automating insulin delivery, responding to glucose changes every five minutes, and supporting more stable glucose control. This means fewer highs and lows, less daily decision‑making, and a more streamlined way to stay within recommended glucose ranges.§

Medicare customers who previously placed orders for the MiniMed 780G system with the Instinct sensor will advance through the standard Medicare billing and fulfillment process, subject to individual eligibility and insurance requirements. Medtronic Diabetes is also working closely with distributor partners to support readiness and timely shipment for eligible customers.

Ultra Rapid-Acting Insulins for MiniMed 780G System

The FDA cleared the MiniMed 780G system for use with ultra rapid-acting insulins Fiasp and Lyumjev, giving people living with type 1 and insulin‑requiring type 2 diabetes more flexibility and personalization in their therapy.

Ultra rapid‑acting insulin more closely mimics the body’s natural insulin response, especially around mealtimes. Its faster onset may help reduce the impact of late or missed meal doses, allowing the insulin to “catch up” more effectively.¹ When paired with the MiniMed 780G system’s unique Meal Detection technology, these insulin options can help take the burden and pressure off mealtimes when carb counts are not exact or a meal dose is sometimes missed or delayed. This new clearance allows clinicians and individuals to choose the insulin that best matches their physiology and lifestyle, supporting more customized therapy and potentially improving overall glucose outcomes.

MiniMed 780G System for Use With Instinct Sensor

The FDA cleared the SmartGuard algorithm as an interoperable automated glycemic controller (iAGC) and the MiniMed 780G insulin pump as an alternate controller enabled (ACE) for insulin-requiring type 2 diabetes, enabling integration with the Instinct sensor, made by Abbott.

People living with insulin‑requiring type 2 diabetes navigate a demanding daily routine that impacts both their physical and emotional well‑being—from multiple injections to constant meal planning and vigilant glucose monitoring. The MiniMed 780G system can help lighten the daily load by automatically adjusting insulin delivery every five minutes and stepping in to help manage missed or underestimated meal boluses. Paired with the Instinct sensor, users will soon have access to the company’s most advanced automated insulin delivery system with the world’s smallest and thinnest integrated sensor that offers up to 15 days of wear, is slim and worn discreetly.^2,3

“Bringing together the Instinct sensor, made by Abbott, with the well-established algorithm of the MiniMed 780G system makes for an extremely effective combination,” said Anders Carlson, M.D., associate executive director, International Diabetes Center, in Minneapolis. “I think anyone who requires insulin therapy to manage their diabetes, whether it’s type 1 or type 2 diabetes, can benefit from automated insulin delivery. I’m thrilled that the MiniMed 780G system with the Instinct sensor is now cleared for this population, so that more people living with type 2 diabetes will get access to this technology improving their day-to-day experience in managing their diabetes.”

The MiniMed 780G system for insulin-requiring type 2 diabetes is now can now be ordered with Instinct along with the Guardian 4 and Simplera Sync sensors. The Instinct sensor, made by Abbott, is currently available for type 1 diabetes.

The MiniMed 780G system is Medtronic’s most advanced automated insulin delivery system that automatically adjusts insulin every five minutes based on real-time glucose readings, helping reduce highs and lows and making diabetes management easier and less time-consuming.§

The Instinct sensor, made by Abbott, offers up to 15 days of wear, is slim and worm discreetly. It’s the world’s smallest and thinnest integrated CGM.^2,3 Ultra rapid-acting insulins enter the bloodstream and start working sooner than traditional rapid‑acting insulins, helping manage post‑meal spikes—especially when individuals can’t or forget to pre‑bolus 15 minutes before eating.⁴

Medtronic Diabetes aims to make diabetes more predictable with the most advanced diabetes technology. The company pioneered first-of-its-kind innovations for more than 40 years and is committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and artificial intelligence (AI). 

Headquartered in Galway, Ireland, Medtronic is a global healthcare technology company that attacks challenging health problems and finds solutions. Its mission to alleviate pain, restore health, and extend life unites more than 95,000 employees across more than 150 countries. Medtronic technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more.

References
¹ Rakab MS, Rateb RM, Elsalakawi BH, Al Zoubi BM, Nazir A, Abu-Laila MM, Ghanem AS, Maamoun A, Mattar M, Ataallah B, Layden BT, Mahmoud AM. Ultra-rapid lispro or fast-acting aspart compared to standard insulin lispro and aspart using closed-loop insulin therapy: a systematic review and meta-analysis of randomized control trials. Front Endocrinol (Lausanne). 2025 Jun 6;16:1600157.
² Among applied sensors.
³ Data on file. Abbott Diabetes Care, Inc.
⁴ Eva Y. Wong, Lisa Kroon; Ultra-Rapid-Acting Insulins: How Fast Is Really Needed?. Clin Diabetes 1 October 2021; 39 (4): 415–423. https://doi.org/10.2337/cd20-0119

§ Refers to SmartGuard feature. Individual results may vary.