Medtronic (NYSE:MDT) today announced three U.S. milestones expanding access to its MiniMed 780G automated insulin delivery system.
The company announced Medicare access for MiniMed 780G paired with the Instinct sensor made by Abbott, FDA clearance for the pairing for insulin-requiring type 2 diabetes and FDA clearance for the system’s use with ultra rapid-acting insulins.
Medtronic and Abbott entered a collaboration in August 2024 to pair insulin delivery and continuous glucose monitoring (CGM) technologies. Medtronic (soon to be a standalone company called MiniMed) launched the MiniMed 780G with the Instinct sensor made by Abbott late last year. The company further advanced the integrated offering with FDA 510(k) clearance for its MiniMed Go app for multiple daily injections (MDI) last month.
MiniMed 780G, the company’s latest-generation AID system, offers meal detection technology and provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs. The algorithm auto-corrects glucose levels to provide support for missed boluses or underestimated carbohydrates.
“These milestones reflect our unwavering commitment to expanding access and giving individuals living with diabetes more choice in how they manage their condition,” said Que Dallara, EVP & 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.”
More about the latest milestones for Medtronic and MiniMed 780G
Medicare
Medtronic said that Medicare and Medicare Advantage beneficiaries can now access MiniMed 780G with Instinct. It expands sensor choice for Medicare users of MiniMed 780G, who also have access to the Simplera Sync and Guardian 4 sensors. This follows expanded U.S. pharmacy formulary access for MiniMed 780G announced last month.
Medicare customers who previously placed orders for MiniMed 780G with Instinct can now advance through the standard Medicare billing and fulfillment process. Medtronic said it has work underway with distribution partners to support readiness and timely shipments.
Type 2
Medtronic said the FDA cleared its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC) and MiniMed 780G as an alternate controller-enabled (ACE) system for insulin-requiring type 2 diabetes, enabling integration with Instinct.
This clearance means people with insulin-requiring type 2 diabetes can receive automated insulin delivery from the integrated offering. It gives users access to the company’s most advanced automated system with the world’s smallest, thinnest integrated sensor, plus 15 days of wear time.
“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 Dr. Anders Carlson, 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 life-changing technology, improving their day-to-day experience in managing their diabetes.”
Rapid-acting insulins
The final milestone came in the form of FDA clearance for MiniMed 780G with a duo of ultra-rapid-acting insulins. Clearance covers use with Fiasp (Novo Nordisk) and Lyumjev (Eli Lilly).
Medtronic said this gives people with both type 1 and 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. This enables insulin to “catch up” more effectively.
According to Medtronic, pairing rapid-acting insulin with its Meal Detection technology can help remove the burden and pressure from mealtimes. The clearance allows clinicians and users to pick the insulin they think best matches their physiology and lifestyle.