MiniMed Announces FDA Clearance of MiniMed Flex(TM), the Company's Smallest Insulin Pump Featuring Its First Smartphone-Controlled Design
MWN-AI** Summary
MiniMed, a leading diabetes technology company, has received FDA clearance for its MiniMed Flex™, a next-generation insulin pump that is both compact and smartphone-controlled. This new device is about half the size of the previous MiniMed 780G system, designed to cater to the needs of individuals managing diabetes seamlessly and discreetly.
The MiniMed Flex™ integrates advanced features, including the SmartGuard™ adaptive algorithm with Meal Detection™ technology, which offers real-time insulin delivery adjustments. The pump holds a 300-unit insulin reservoir and is designed for convenience, allowing users to wear it comfortably—either hidden or in their pockets. This innovative screenless design provides management via a compatible app on both iOS and Android devices, facilitating easy access and updates without the need for a traditional pump screen.
The launch also includes a MiniMed Forward Program, which allows current MiniMed 780G users to transition to the Flex™ system at no extra cost. This upgrade process is intended to be straightforward given the compatibility with existing infusion set portfolios.
MiniMed Flex™ is suitable for individuals aged 7 and older with type 1 diabetes and adults 18 and older with insulin-requiring type 2 diabetes. With the aim of enhancing daily life for diabetes patients by minimizing management burdens, MiniMed articulated its commitment to innovation in the sector, particularly as it marks its first major product release following its recent IPO. With the extensive clinical validation and reports suggesting an 80% Time in Range with recommended settings, the MiniMed Flex™ represents a significant advancement in diabetes care technology.
MWN-AI** Analysis
The recent FDA clearance for MiniMed's new product, the MiniMed Flex™, marks a significant milestone not only for the company but also for the diabetes management market. This innovative, smartphone-controlled insulin pump is expected to transform the way users interact with their diabetes care, providing a discreet and efficient solution.
With its compact design—about half the size of its predecessor, the MiniMed™ 780G—the MiniMed Flex™ is poised to attract a broader demographic of users, particularly tech-savvy individuals seeking convenience. The device's advanced SmartGuard™ adaptive algorithm enhances insulin delivery by automatically adjusting to real-time glucose levels, which could lead to improved patient outcomes and satisfaction.
Market analysts should pay close attention to MiniMed's forthcoming commercial launch slated for this summer, as demand for innovative diabetes management solutions continues to rise. Notably, the device's integration with the Simplera Sync™ sensor and Abbott's Instinct sensor further strengthens MiniMed's ecosystem, presenting cross-selling opportunities that could enhance revenue streams.
From an investment standpoint, MiniMed (Nasdaq: MMED) remains attractive due to its pioneering position in the diabetes technology sector. The successful launch of MiniMed Flex™ could lead to market share expansion, especially as the company implements its MiniMed™ Forward Program to facilitate smooth transitions for current users of the MiniMed™ 780G system.
However, investors should remain cautious, as competitive pressures from other diabetes technology firms could impact market dynamics. Overall, the prospects for MiniMed look promising in the near term, driven by innovative product offerings and a commitment to improving patient quality of life. Monitoring the product adoption rates and customer feedback post-launch will be critical for evaluating MiniMed's long-term growth potential.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
MiniMed Flex™ is about 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., March 18, 2026 /PRNewswire/ -- MiniMed (Nasdaq: MMED), a global leader in diabetes technology, today announced U.S. Food and Drug Administration (FDA) clearance of MiniMed Flex™, a next-generation discreet, smartphone-controlled insulin pump designed to fit seamlessly into everyday life.
About half the size* of the MiniMed™ 780G pump and roughly the size of two stacked insulin vials, MiniMed Flex™ is the company's first screenless design created in partnership with people living with diabetes to deliver an intuitive, lifestyle?friendly way to manage the condition. MiniMed Flex™ is powered by the company's most advanced SmartGuard™ algorithm with Meal Detection™ technology, which has proven clinical performance that exceeds worldwide Time in Range recommendations.1,2 At commercial launch, MiniMed Flex™ will support the company's newest sensor portfolio, including Simplera Sync™ sensor and the Instinct sensor, made by Abbott.
"At MiniMed, our Mission is to make every day a better day for people with diabetes," said Que Dallara, chief executive officer of MiniMed. "MiniMed Flex™ embodies that promise. It's designed to work quietly and reliably in the background — advanced automation wrapped in a compact, smartphone?controlled pump. The result is technology that lets people spend less time managing diabetes and more time living their lives. Securing FDA clearance for our first product as a standalone, public company — just one week after our IPO — marks a major milestone and underscores our commitment to delivering the breakthrough innovation our customers deserve."
MiniMed Flex™ represents a major redesign of MiniMed's insulin pumps. Key features include:
- Small, sleek design with high insulin capacity: Designed to be worn wherever users prefer — in a pocket or out of sight — while delivering a 300-unit insulin reservoir to support a range of insulin needs.
- Smartphone-controlled: Managed through a compatible mobile app, eliminating the traditional pump screen, with seamless software updates delivered through iOS and Android devices at launch.
- Sensor compatibility: At commercial launch, MiniMed Flex™ will support the company's newest sensor portfolio, including Simplera Sync™ sensor and the Instinct sensor, made by Abbott.
- Extended infusion set options: Works with MiniMed's infusion set portfolio, including the Extended™ infusion set with up to 7 days of wear, delivering up to 96% fewer injections compared with traditional insulin therapy.?
- Proven AID performance: Real-world results have demonstrated 80% Time in Range with recommended settings.3**
"MiniMed Flex™ represents an important leap forward for MiniMed," said Anders Carlson, MD, Medical Director of the International Diabetes Center at Park Nicollet, Director of the HealthPartners Diabetes Program, and an assistant professor in the University of Minnesota Medical School. "For many people living with diabetes, the burden of daily management can be overwhelming. By combining a discreet, screenless form factor with a powerful adaptive algorithm that responds quickly to changes in glucose, MiniMed Flex™ brings meaningful innovation exactly where it's needed—into the flow of everyday life. This level of automation, paired with the freedom of smartphone control, has the potential to improve consistency, confidence, and ultimately clinical outcomes for a broad range of patients with diabetes."
Launch of MiniMed™ Forward Program: Enabling a Seamless Upgrade from the MiniMed™ 780G system to MiniMed Flex™ system
MiniMed also announced the MiniMed™ Forward Program, which allows customers who start on the MiniMed™ 780G system to upgrade to the MiniMed Flex™ system for $0.*** New MiniMed™ 780G system users who enroll in the program will be notified when the MiniMed Flex™ system becomes commercially available in the U.S. and will receive instructions for completing the upgrade.
The launch of the MiniMed Flex™ system will begin with a customer experience phase this spring involving select current MiniMed customers, followed by a broader commercial launch planned for the summer.
MiniMed Flex™ is cleared for individuals ages 7 and older with type 1 diabetes, and for individuals 18 years and older with insulin-requiring type 2 diabetes.
Frequently Asked Questions
Q: What is the MiniMed Flex™ system?
A: The MiniMed Flex™ system is MiniMed's next-generation automated insulin delivery system featuring a small, smartphone-controlled insulin pump powered by the proven SmartGuard™ algorithm with Meal Detection™ technology. The system includes a 7-day infusion set, a 300-unit reservoir, and is designed with a compact form factor for users to wear as they like — in a pocket or out of sight.
Q: Can current MiniMed™ 780G users upgrade to MiniMed Flex™ system?
A: Yes. Eligible users of the MiniMed™ 780G system may upgrade to MiniMed Flex™ through the MiniMed™ Forward Program. Because MiniMed Flex™ maintains compatibility with MiniMed's existing reservoir and infusion set portfolio, the transition is designed to be straightforward for current users.
Q: What sensors are compatible with MiniMed Flex™ system?
A: At commercial launch, MiniMed Flex™ will support the company's newest sensor portfolio, including Simplera Sync™ sensor and the Instinct sensor, made by Abbott.
About MiniMed
MiniMed is a global leader in insulin delivery, constantly advancing therapies that support people with diabetes in 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 filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
*Pump dimensions on File – IFU Labeling. Overall size related to volume.
**Due to inherent real-world study limitations, caution is advised when attempting to extrapolate these results to new patients. There could be significant differences.
***Applies to customers who have purchased a MiniMed™ 780G system between February 18, 2026, and launch.
? Assumes 4 injections per day for 30 days and one infusion set change every seven days
- Arrieta A, et al. Diabetes Obes Metab. 2022;10.1111/dom.14714.
- American Diabetes Association Professional Practice Committee; 13. Older Adults: Standards of Care in Diabetes—2025. Diabetes Care 1 January 2025; 48 (Supplement_1): S266–S282.
- Nally LM, et al.; SUCCEED Study Group. Safety and Glycemic Outcomes of the MiniMed 780G System with a Disposable All-in-One Sensor. Diabetes Technol Ther. 2026 Feb;28(2):109-120. doi: 10.1177/15209156251368928.
SOURCE MiniMed
FAQ**
How does MiniMed Group Inc. MMED plan to market the MiniMed Flex™ to differentiate it from competitors in the automated insulin delivery market, especially considering its innovative smartphone-controlled design?
What feedback from users living with diabetes influenced the development of MiniMed Flex™, and how does the company measure user satisfaction post-launch with this new product from MiniMed Group Inc. MMED?
Given the successful FDA clearance, what are MiniMed Group Inc. MMED's projected timelines for the commercial launch of MiniMed Flex™, and what strategies will be employed to ensure a smooth transition for existing MiniMed™ 780G users to the new system?
Can you elaborate on the potential market impact of the MiniMed Flex™ system's adaptive SmartGuard™ technology and Meal Detection™ feature on patient outcomes in diabetes management, as outlined by MiniMed Group Inc. MMED's clinical performance data?
**MWN-AI FAQ is based on asking OpenAI questions about MiniMed Group Inc. (NASDAQ: MMED).
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