Medtronic Diabetes announces FDA clearance for MiniMed Go Smart MDI system featuring Instinct sensor made by Abbott

MiniMed Go™ is the first and only smart MDI system that automatically integrates insulin dosing and glucose data in a single app to provide empowering insights for individuals on multiple daily injections

GALWAY, Ireland, Jan. 12, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its MiniMed Go™ app. The MiniMed Go™ Smart Multiple Daily Injection (MDI) system seamlessly integrates the InPen™ smart insulin pen with the Instinct sensor made by Abbott — all connected through the MiniMed Go™ app. This powerful combination delivers real-time, personalized insights and actionable guidance, including:

• Missed dose alerts to help minimize glucose highs
• A dose calculator that simplifies dose decision-making
• Action-oriented guidance if a user misses or miscalculates a dose
• CareLink™ software reporting for easier provider collaboration

The MiniMed Go™ system is cleared for individuals with insulin-requiring type 1 and type 2 diabetes aged 7 years and older, as well as for children ages 2 to 6 years under the supervision of an adult caregiver. Compatibility of the Simplera™ sensor with MiniMed Go™ is currently under FDA review.

Addressing a Significant Unmet Need 

There are more than 15 million people around the world with diabetes who rely on multiple daily injections. For these individuals, mealtimes can feel overwhelming and exhausting — and over time, this can lead to diabetes distress.^1,2 This involves determining the amount of carbs in their meal and calculating the right insulin dose to inject before eating (bolus) to keep blood sugar levels in check to avoid dangerous spikes or dips.

Missed boluses can significantly impact diabetes management and glycemic outcomes. Even skipping just two doses a week can raise HbA1C by as much as 0.4%, increasing the risk of both short- and long-term complications.³ Remembering when and how much insulin to dose isn't just a math problem — it's a daily burden that adds stress and fatigue, making diabetes management feel overwhelming.

Real-world data demonstrates that users of the previous generation Medtronic Smart MDI system saw meaningful improvements in glycemic control when consistently responding to actionable alerts. Specifically, the data showed that Time in Range (TIR) increased from 55.7% to 67.2% when users addressed more than 75% of Missed Dose alerts within an hour, and to 71.5% when users addressed Correct High Glucose alerts with a bolus within an hour. These results underscore the power of timely, actionable insights in helping users achieve better glycemic outcomes.⁴ The new MiniMed Go™ Smart MDI System delivers real-time, personalized insights and actionable guidance to optimize outcomes for users.

"For too long, people using injections have carried the weight of diabetes management without access to the algorithms that make automated insulin delivery systems so powerful," said Que Dallara, EVP and president of Medtronic Diabetes and CEO-designate of MiniMed. "MiniMed Go™ is designed to change that — bringing the smarts of an AID system to individuals who prefer an insulin pen. The system helps take the guesswork out of MDI therapy, delivering simplicity and confidence in every dose. We're pleased to expand our full-stack insulin delivery solutions, making it seamless for our customers to find a therapy that works for them — no matter where they are in their journey."

We expect the commercial launch of the MiniMed Go™ system to begin in the U.S. this spring.  Learn more here about MiniMed Go™.  

Frequently Asked Questions

Q: What is the MiniMed Go™ system?

A: The MiniMed Go™ system is a smart diabetes management solution that connects the InPen™ smart insulin pen and the Instinct sensor made by Abbott through the MiniMed Go™ app. It provides real-time glucose data, dose calculations, missed dose alerts, and actionable guidance, making MDI therapy easier and more connected.

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 is the Instinct sensor and how is it different?

A: Instinct, made by Abbott, offers up to 15 days of wear and a slim, discreet design. It's the world's smallest⁵ and thinnest⁶ integrated CGM.⁶

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 (NYSE: MDT), visit www.Medtronic.com and follow 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.

*Data was uploaded voluntarily from 22 October 2024 until 04 January 2025 in the CareLink™ Personal platform. Data aggregation and analysis was based on user consent and complied with local data privacy regulations.

⁺Sensor is water resistant up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes.

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.

1. Bergenstal RM, et al. Exploring the Burden of Mealtime Insulin Dosing in Adults and Children With Type 1 Diabetes. Diabetes Care. 2021; Published online.
2. Monaghan M, Herbert LJ, Wang J, Holmes C, Cogen FR, Streisand R. Mealtime behavior and diabetes-specific parent functioning in young children with type 1 diabetes. Health Psychol. 2015 Aug;34(8):794-801. doi: 10.1037/hea0000204. Epub 2015 Feb 9. Published online.
3. 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.
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.
5. Among patient-applied sensors.
6. Data on file. Abbott Diabetes Care, Inc.

Contacts:

Janet Cho

Global Communications

+1 (818) 403-7028

Ryan Weispfenning

Investor Relations

+1 (763) 505-4626 

SOURCE Medtronic plc