Medtronic Diabetes expands access to full-stack insulin delivery solutions with Medicare access and new FDA clearances
Rhea-AI Summary
Medtronic (NYSE: MDT) announced three U.S. milestones on Feb 2, 2026: Medicare access for the MiniMed 780G system paired with Abbott's Instinct sensor, FDA clearance to use ultra rapid-acting insulins (Fiasp and Lyumjev) with the 780G, and FDA clearance of the 780G with Instinct for insulin-requiring type 2 diabetes.
These actions expand sensor and insulin options, enable interoperable automated glycemic control for type 2 users, and aim to broaden access and personalization for people using automated insulin delivery.
Positive
- Medicare access for MiniMed 780G with Abbott Instinct sensor expands coverage
- FDA cleared use of ultra rapid-acting insulins Fiasp and Lyumjev with 780G
- FDA cleared 780G SmartGuard as iAGC and pump as ACE for insulin-requiring type 2
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
MDT gained 1.94% while peers were mixed: SYK +0.12%, BSX +0.52%, ZBH +0.89% versus EW -0.29% and PHG -0.38%, indicating a company-specific reaction.
Previous Fda approval Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Sep 19 | Device FDA approval | Positive | -0.5% | Altaviva™ device FDA approval for urge urinary incontinence therapy. |
| Sep 02 | Diabetes FDA clearance | Positive | +0.6% | MiniMed™ 780G cleared with Instinct sensor and approved for type 2 diabetes. |
| Apr 18 | Sensor FDA approval | Positive | -1.0% | FDA approval of Simplera Sync™ sensor for MiniMed™ 780G system. |
| Feb 24 | Neurology FDA approval | Positive | +0.3% | FDA approval for BrainSense™ Adaptive deep brain stimulation system. |
| Oct 24 | EP system FDA approval | Positive | -0.4% | FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter. |
Recent FDA approvals for MDT have generally been positive catalysts but often saw muted or negative next-day moves, with only 2 of 5 same-tag events showing positive price reactions.
Over the past year, Medtronic has repeatedly secured U.S. FDA approvals across neuromodulation, electrophysiology, and diabetes, including BrainSense™ Adaptive DBS and multiple MiniMed™ 780G and sensor clearances. These announcements, along with the Altaviva™ urinary incontinence device and Affera™ mapping and ablation system, underline a steady cadence of regulatory wins. Despite this, share reactions were mixed, with some approvals followed by modest declines, so today’s positive response to new MiniMed™ 780G clearances and Medicare access fits within a pattern of strong fundamentals but variable trading.
Historical Comparison
In the past year, MDT’s five FDA approval headlines averaged a 0.55% move. Today’s FDA clearances and Medicare access for MiniMed™ 780G fit this ongoing regulatory momentum, with a somewhat stronger pre-news gain of 1.94%.
FDA events trace a progression from core neuromodulation and electrophysiology approvals to increasingly integrated diabetes solutions, including MiniMed™ 780G system enhancements and sensor approvals.
Market Pulse Summary
This announcement expands the MiniMed™ 780G ecosystem with Medicare coverage for the Instinct sensor, clearance for ultra rapid-acting insulins, and broader use in insulin-requiring type 2 diabetes. It builds on a year of frequent FDA approvals where average same-tag moves were about 0.55%. Key factors to monitor include actual uptake among Medicare beneficiaries, clinician adoption of ultra rapid-acting insulins in automated systems, and progress on the planned MiniMed IPO.
Key Terms
automated insulin delivery medical
continuous glucose monitoring medical
AI-generated analysis. Not financial advice.
"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."
Medicare Access for MiniMed™ 780G System with Instinct Sensor, Made by Abbott
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. This milestone 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 now 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 aren't 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 FDA Cleared for Type 2 Diabetes
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, MD, Associate Executive Director, International Diabetes Center in
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. Learn more about the MiniMed™ 780G system here.
Frequently Asked Questions
Q: What is the MiniMed™ 780G system?
A: It's 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.§
Q: What makes the Instinct sensor different?
A: 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
Q: What is ultra rapid-acting insulin and the benefit for AID systems?
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
About the Diabetes Business at Medtronic
Medtronic Diabetes is on a mission to make diabetes more predictable with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
- 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.
- Among applied sensors.
- Data on file. Abbott Diabetes Care, Inc.
- 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
The sensor shape and appearance, Abbott, and Instinct are marks and/or designs of the Abbott group of companies in various territories and used under license.
Fiasp is a registered trademark of Novo Nordisk A/S and Lyumjev is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
Contacts:
Janet Cho
Global Communications
+1 (818) 403-7028
Ryan Weispfenning
Investor Relations
+1 (763) 505-4626
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SOURCE Medtronic plc
FAQ
What does the Medicare access announced Feb 2, 2026 mean for MDT shareholders?
How does FDA clearance for ultra rapid-acting insulins affect MiniMed 780G users (MDT)?
Is the MiniMed 780G now FDA-cleared for insulin-requiring type 2 diabetes (MDT)?
What sensor options are now available for Medicare customers buying the MiniMed 780G (MDT)?
How might these milestones impact clinical use and patient experience with the MiniMed 780G (MDT)?
