Medtronic begins EMEA commercial launch of MiniMed Go Smart MDI system with Simplera sensor

Rhea-AI Summary

Medtronic (NYSE: MDT) launched the MiniMed Go™ Smart MDI system with the Simplera™ sensor across Europe beginning Feb 2026. The system integrates InPen™ smart insulin pen and Simplera™ CGM into one app, offering real-time dose calculation, missed-dose alerts, CareLink Clinic MDI reports, and expanded pediatric labeling.

Rollout is gradual across Europe; Instinct Go™ compatibility is pending CE mark and Simplera™ compatibility in the U.S. is under FDA review.

Positive

• Integrated platform: first all-in-one app combining InPen and Simplera sensor
• Pediatric approval: cleared for ages 7+, and 2–6 with caregiver supervision
• Real-world TIR improvement: prior Smart MDI users responding to alerts saw TIR up to 71.5%

Negative

• European rollout is gradual, limiting immediate market penetration
• Key compatibility items pending: Instinct Go CE mark and Simplera U.S. FDA review

Key Figures

HbA1C increase: up to 0.4 Time in Range decrease: more than 5% Time in Range (responsive users): 67.2% +5 more

8 metrics

HbA1C increase up to 0.4 Impact from skipping two insulin doses per week

Time in Range decrease more than 5% Effect of missing two basal or four bolus doses over 14 days

Time in Range (responsive users) 67.2% Users responding to >75% missed dose alerts within one hour

Cohort mean Time in Range 55.7% Average TIR for overall Smart MDI cohort

High-glucose alert TIR up to 71.5% Users addressing high blood sugar alerts

Minimum approved age 7 years and older People with insulin-requiring diabetes in Europe using MiniMed Go

Supervised pediatric age 2 to 6 years Children eligible under adult caregiver supervision in Europe

Smart MDI users dataset 1,852 users First type 1 diabetes users in real-world Smart MDI data

Market Reality Check

Price: $96.75 Vol: Volume 7,567,517 is 0.81x...

normal vol

$96.75 Last Close

Volume Volume 7,567,517 is 0.81x the 20-day average of 9,296,448, indicating no elevated trading interest ahead of this news. normal

Technical Shares at $96.75 trade above the 200-day MA of $93.81 and about 9.01% below the 52-week high of $106.33.

Peers on Argus

MDT fell 1.89% while key peers were mixed: SYK -0.77%, BSX +0.87%, EW +0.09%, ZB...

MDT fell 1.89% while key peers were mixed: SYK -0.77%, BSX +0.87%, EW +0.09%, ZBH +0.11%, PHG 0%. The directional split suggests today’s move was more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Feb 17 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 17	Q3 FY26 results	Positive	-3.1%	Strong Q3 revenue and EPS above guidance midpoint with reiterated outlook.
Feb 17	Robotics milestone	Positive	-3.1%	First U.S. commercial surgery using FDA-cleared Hugo RAS system at Cleveland Clinic.
Feb 13	FDA clearance	Positive	-1.4%	FDA clearance of Stealth AXiS platform integrating planning, navigation and robotics.
Feb 11	Earnings scheduling	Neutral	-0.3%	Announcement of date and webcast details for Q3 FY26 financial results.
Feb 03	Acquisition plan	Positive	+0.5%	Intent to acquire CathWorks for up to $585M to expand cardiology portfolio.

Pattern Detected

Recent positive operating and regulatory updates have often coincided with short-term share price weakness, showing a tendency for negative or muted reactions even to constructive news.

Recent Company History

Over the last month, Medtronic reported strong Q3 FY26 results with revenue of $9.017 billion and reiterated its FY26 outlook, yet shares fell 3.1%. Multiple technology milestones followed, including first U.S. surgery with the Hugo robotic-assisted surgery system and FDA clearance of the Stealth AXiS spine platform, both meeting key safety and effectiveness endpoints but again seeing negative next-day moves. The CathWorks acquisition announcement for up to $585 million drew a modestly positive reaction. Today’s EMEA MiniMed Go Smart MDI launch fits this pattern of ongoing product and portfolio expansion.

Market Pulse Summary

This announcement expands Medtronic’s diabetes portfolio with the MiniMed Go Smart MDI system launch...

Analysis

This announcement expands Medtronic’s diabetes portfolio with the MiniMed Go Smart MDI system launch across Europe, integrating the InPen smart insulin pen and Simplera sensor into a single app. Real-world data cited include Time in Range up to 71.5% for engaged users versus a cohort mean of 55.7%. In context of recent strong Q3 FY26 results and multiple device clearances, investors may monitor European uptake, regulatory progress on additional sensors, and how these offerings support the planned MiniMed diabetes business separation.

Key Terms

continuous glucose monitoring, hba1c, ce mark, fda, +3 more

7 terms

continuous glucose monitoring medical

"integration of real-time continuous glucose monitoring, a built-in dose calculator"

Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.

hba1c medical

"skipping just two doses per week may increase HbA1C by up to 0.4"

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

ce mark regulatory

"Compatibility of the Instinct Go™ sensor... is currently pending CE mark approval."

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

fda regulatory

"Compatibility of the Simplera™ sensor with MiniMed Go™ is currently under FDA review."

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

telemedicine technical

"Combined with efficient telemedicine delivery, we're able to provide more personalised"

Telemedicine is the delivery of healthcare services remotely through digital communication tools, such as video calls or online messaging. It allows patients to consult with doctors and medical professionals without visiting a clinic in person. For investors, telemedicine represents a growing sector that combines technology and healthcare, potentially transforming how medical care is accessed and delivered worldwide.

bluetooth technical

"The InPen™ is a reusable smart insulin pen that uses Bluetooth® technology"

A wireless communication standard that lets nearby devices exchange data without cables, like an invisible short-range cord linking phones, headphones, sensors and cars. For investors, Bluetooth matters because it shapes how easily products connect, influences consumer demand and user experience, affects sales of chips and accessories, and creates recurring value through ecosystem compatibility and licensing—factors that can drive revenue and competitive position.

continuous glucose monitoring outcomes medical

"Association Between Treatment Adherence and Continuous Glucose Monitoring Outcomes"

Continuous glucose monitoring outcomes are the measurable results produced by wearable sensors that track a person’s blood sugar around the clock, such as how long levels stay in a healthy range, average sugar levels, fluctuations, and episodes of low or high sugar. Investors care because these outcomes show whether a device or therapy actually improves health, affects regulatory approval and insurance coverage, and drives user adoption and sales—like a performance report card for the product.

AI-generated analysis. Not financial advice.

Real-time actionable insights on one mobile app for people who manage their diabetes using multiple daily injections

GALWAY, Ireland, Feb. 25, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced the commercial launch in Europe of the MiniMed Go™ Smart MDI system with the Simplera™ sensor. The system, which is the first and only solution to integrate data from the InPen™ smart insulin pen and the Simplera™ sensor into a single mobile app, is designed to help people who use multiple daily injections (MDI) to better control their diabetes. The launch will be rolled out gradually across Europe starting this month.

The MiniMed Go™ Smart MDI system marks a departure from traditional and basic connected insulin pens. It provides real-time, personalized insights, actionable dose alerts, a built-in advanced dose calculator, and continuous guidance — all accessible through a smartphone app. This intelligent decision support tool aims to address daily challenges faced by those managing diabetes with MDI.

Missing insulin doses (boluses) can significantly impact glycemic control. Research shows that skipping just two doses per week may increase HbA1C by up to 0.4,¹ raising the risk of both short- and long-term complications.² Another study found that missing two basal doses or four bolus doses over 14 days was linked to more than a 5% decrease in Time in Range.³ Real-world data ⁴ from the previous generation of the Medtronic Smart MDI system demonstrated that users who responded to more than 75% of missed dose alerts within one hour achieved Time in Range (TIR) of 67.2% compared to the mean TIR for the cohort at 55.7%, and up to 71.5% TIR when addressing high blood sugar alerts.

"Real-time actionable alerts are becoming the key to better clinical outcomes for people with diabetes using multiple daily injections," said Que Dallara, EVP and president of Medtronic Diabetes and CEO-designate of MiniMed. "The MiniMed Go™ system remembers, reminds and recommends the right dose at the right time so you don´t have to." ^†

For busy healthcare professionals, the MiniMed Go™ system includes new CareLink Clinic MDI reports, that make it easier for clinicians to interpret user data and support more informed patient discussions. 

"Smart MDI has fundamentally changed how we care for patients on multiple daily injections," said Dr Martín Cuesta Hernández, Endocrinologist, Hospital Clinico San Carlos - Madrid, Spain. "We're now making evidence-based decisions instead of relying on assumptions, which has strengthened trust and improved the quality of our conversations with patients. Many people simply tell us they're delighted because life is easier. Combined with efficient telemedicine delivery, we're able to provide more personalised, effective care than ever before."

In Europe, the MiniMed Go™ system with Simplera™ sensor is approved for people with insulin-requiring diabetes aged 7 years and older, as well as for children aged 2 to 6 years under the supervision of an adult caregiver. Compatibility of the Instinct Go™ sensor, made by Abbott, with MiniMed Go™ in Europe is currently pending CE mark approval. Once approved, users will have the choice between a 7-day or 15-day sensor depending on what best fits their needs.

Frequently Asked Questions
Q: What is the MiniMed Go™ system?
A: In Europe, the MiniMed Go™ system is a smart diabetes management solution that connects the InPen™ smart insulin pen with the Simplera™ sensor through the single MiniMed Go™ app. It provides real-time glucose data, dose calculations, missed dose alerts, and actionable guidance, making MDI therapy easier and more connected. CE mark approval is pending on integration with the Instinct Go™ sensor made by Abbott. In the U.S., the MiniMed Go™ Smart Multiple Daily Injection (MDI) system seamlessly integrates the InPen™ smart insulin pen with the Instinct sensor. Compatibility of the Simplera™ sensor with MiniMed Go™ is currently under FDA review.

Q: What is InPen™? 
A: The InPen™ is a reusable smart insulin pen that uses Bluetooth® technology to send dose information to a mobile app. Offering dose calculations and tracking, InPen™ helps take some of the mental math out of diabetes management.

Q: What's the difference between the MiniMed Go™ Smart MDI system and the previous Medtronic Smart MDI system with Simplera™ sensor?
A: There are a few upgrades including a single unified mobile app experience, easier onboarding, support and self-training tools, new features and insulin settings. For healthcare professionals, new CareLink Clinic dedicated MDI reports turn patient data into clinical and behavioural insights, making consultations more efficient.

Q: What is the difference between the MiniMed Go™ Smart MDI system and traditional pens or other connected pens for diabetes?
A: Unlike traditional insulin pens, which lack the ability to track doses or provide decision support, the MiniMed Go™ Smart MDI system offers integration of real-time continuous glucose monitoring, a built-in dose calculator that simplifies dose decision-making, and smart dosing alerts to help people with their diabetes therapy adherence – the first and only Smart MDI system to offer an all in one mobile app.

† Proper settings, connectivity, and some manual logging required. See user guides for full details and important safety information.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license.

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.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ingrid Goldberg
Investor Relations
+1-763-505-2696

1	Randlov, J, Poulsen, JU. How Much Do Forgotten Insulin Injections Matter to Hemoglobin A1c in People with Diabetes, J Diabetes Sci Technol. 2008; 2(2):229-235.
2	American Diabetes Association Professional Practice Committee for Diabetes. Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan
3	Danne TPA, Joubert M, Hartvig NV, Kaas A, Knudsen NN, Mader JK. Association Between Treatment Adherence and Continuous Glucose Monitoring Outcomes in People With Diabetes Using Smart Insulin Pens in a Real-World Setting. Diabetes Care. 2024 Jun 1;47(6):995-1003. doi: 10.2337/dc23-2176. PMID: 38569055; PMCID: PMC11116913.
4	Laurenzi A, Edd SN, Adolfsson P, et al. Insights into the effective use of the Smart MDI system: Data from the first 1852 type 1 diabetes users. Diabet Med. 2025;42(12):e70161. doi:10.1111/dme.70161.

 

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SOURCE Medtronic plc

FAQ

What is the MiniMed Go Smart MDI system (MDT) launched in Europe on Feb 25, 2026?

The MiniMed Go Smart MDI system is an integrated app linking InPen and Simplera to support MDI dosing. According to the company, it provides real-time glucose data, a dose calculator, missed-dose alerts, and clinician CareLink Clinic MDI reports to aid treatment decisions.

Who is eligible to use Medtronic's MiniMed Go with Simplera sensor in Europe (MDT)?

In Europe, the system is approved for insulin-requiring people aged 7 years and older, and for ages 2–6 with adult caregiver supervision. According to the company, these labeling details define clinical eligibility and caregiver guidance.

How might the MiniMed Go system (MDT) affect Time in Range for MDI users?

Real-world data showed users responding to missed-dose alerts achieved TIR up to 71.5%. According to the company, prior Smart MDI users who addressed alerts within one hour saw higher mean TIR versus the broader cohort.

What compatibility limitations should investors note about MiniMed Go (MDT) at launch?

Compatibility with Abbott's Instinct Go sensor in Europe is pending CE mark, and Simplera compatibility with MiniMed Go in the U.S. is under FDA review. According to the company, these pending approvals affect sensor choice availability.

What clinician tools accompany MiniMed Go to support diabetes care (MDT)?

The system includes new CareLink Clinic MDI reports to convert patient data into clinical and behavioral insights. According to the company, these reports are intended to make consultations more efficient and inform evidence-based decisions.