MiniMed Flex™ is approximately half the size of the previous generation MiniMed™ 780G system, and features the SmartGuard™ adaptive algorithm to automatically adjust and autocorrect insulin delivery in real-time.

NORTHRIDGE, Calif., September 1, 2026 – MiniMed (Nasdaq: MMED), a global leader in diabetes technology, today announced CE (Conformité Européenne) Mark for the MiniMed Flex™, the Company’s next generation, app-controlled insulin pump designed to fit seamlessly into daily life.

“This is a proud moment for our team and an important step forward for people living with diabetes across Europe,” said Que Dallara, CEO of MiniMed. “We believe diabetes technology should deliver best-in-class clinical outcomes while being discreet enough to fade into everyday life. This milestone brings us closer to making that experience available to more people across Europe.”

Designed to help reduce the daily burden of living with diabetes, the MiniMed Flex™ system combines dependable clinical performance with greater freedom and discretion. About half the size* of other MiniMed pumps, it is MiniMed’s most compact insulin pump while still holding 300 units of insulin. With an easy-to-use app interface for discreet control, it is designed to be worn more flexibly and comfortably — whatever a person chooses to wear.

Powered by MiniMed’s most advanced SmartGuard™ algorithm, the MiniMed Flex™ system joins the MiniMed™ 780G system as the only systems with Meal Detection™ technology, which detects rapid rises in sensor glucose and delivers a correction dose when meal boluses are occasionally missed or carbohydrate counts are underestimated.^§ Working seamlessly in the background, the system continuously adjusts and autocorrects insulin delivery up to every 5 minutes^‡ using real-time glucose readings from a MiniMed sensor, helping users spend more time in target range with less daily effort. Real-world results have demonstrated 80% Time in Range (TIR)^1,2 with recommended settings — exceeding worldwide TIR recommendations.^◊ Compatible with MiniMed’s Extended™ infusion set, the system can also support up to seven days of wear and up to 96% fewer injections compared with traditional insulin therapy.^Δ

Today's CE mark announcement builds on a series of recent innovations introduced in Europe, including the MiniMed Go™ Smart MDI system and the ongoing rollout of the Instinct and Instinct Go sensors — made by Abbott for use with MiniMed smart dosing systems. MiniMed recently launched the MiniMed Flex™ system with both the Simplera Sync™ and Instinct sensors in the United States.

“What stands out most to me about the MiniMed Flex™ system is how simple and seamless it feels. The pump is lighter and being able to manage everything from my phone means I hardly ever interact with the pump itself,” said Mattie Fisher, a MiniMed customer and participant in an early customer pilot in the U.S.

MiniMed anticipates the European commercial launch of the MiniMed Flex™ system will begin with a customer experience phase later this year in select European countries, followed by a broader commercial launch toward the end of 2026. The Company will showcase MiniMed Flex™ at the European Association for the Study of Diabetes (EASD) in Milan from 28 September - 02 October.  

MiniMed also today announced a program planned for select European countries that will allow eligible existing and new MiniMed™ 780G system users to enroll for an upgrade to the MiniMed Flex™ system when it becomes commercially available in their country.

In Europe the MiniMed Flex™ system is indicated for use by individuals aged 2 years and older with insulin-treated diabetes (type 1 and type 2). The system is also CE Marked in Europe for use during pregnancy.

Frequently Asked Questions
Q: What is the MiniMed Flex™ system?

A: The MiniMed Flex™ system is MiniMed's smallest and only app-controlled automated insulin delivery system. Powered by SmartGuard™ technology, it automatically adjusts insulin delivery around the clock based on real-time glucose levels and includes Meal Detection™ technology to help compensate when a meal bolus is occasionally missed or carbohydrates are underestimated.

Q: What sensors are compatible with MiniMed Flex™ system?

A: At commercial launch in Europe, the MiniMed Flex™ system will support the company's newest sensor portfolio, including Simplera Sync™ sensor and the Instinct sensor, made by Abbott.

Q: Which algorithm is integrated with the MiniMed Flex™ system?

A: The MiniMed Flex™ system is powered by MiniMed's most advanced SmartGuard™ algorithm — the only system with Meal Detection™ technology that detects rapid rises in sensor glucose and delivers a correction dose for occasional missed meal boluses or underestimated carb counts.^§

About MiniMed
MiniMed is a global leader in insulin delivery, constantly advancing therapies that support people with diabetes in more than 80 countries. Our full-stack, integrated ecosystem, including our insulin delivery systems, CGMs, algorithms, and easy-to-use app experience, is designed to work seamlessly together, supported by white-glove, wrap-around service. For over 40 years, we've pioneered therapies people can rely on by anticipating needs, reducing burden, and helping make life with diabetes easier. Our mission is to make every day a better day for people with diabetes.

Any forward-looking statements are subject to risks and uncertainties such as those described in MiniMed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

*Compared to MiniMed™ 780G pump

§ Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.

‡ Refers to SmartGuardTM feature. Individual results may vary.

◊ Due to inherent real-world study limitations, caution is advised when attempting to extrapolate these results to new patients. There could be significant differences.

Δ Assumes 4 injections per day for 30 days and one infusion set change every seven days.

1. Thrasher JR, Arrieta A, Niu F, Cameron KR, Cordero TL, Shin J, Rhinehart AS, Vigersky RA. Early Real-World Performance of the MiniMed™ 780G Advanced Hybrid Closed-Loop System and Recommended Settings Use in the United States. Diabetes Technol Ther. 2024 Mar;26(S3):24-31. doi: 10.1089/dia.2023.0453. PMID: 38377317

2.Choudhary P, Arrieta A, van den Heuvel T, Castañeda J, Smaniotto V, Cohen O. Celebrating the Data from 100,000 Real-World Users of the MiniMed™ 780G System in Europe, Middle East, and Africa Collected Over 3 Years: From Data to Clinical Evidence. Diabetes Technol Ther. 2024 Mar;26(S3):32-37. doi: 10.1089/dia.2023.0433. PMID: 38377326; PMCID: PMC10890936.

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