MiniMed Announces FDA Clearance of MiniMed Flex™, the Company's Smallest Insulin Pump Featuring Its First Smartphone-Controlled Design

MiniMed (Nasdaq: MMED) announced FDA clearance of MiniMed Flex™ on March 18, 2026, a screenless, smartphone‑controlled insulin pump about half the size of the 780G with a 300‑unit reservoir.

Rhea-AI Summary

MiniMed (Nasdaq: MMED) announced FDA clearance of MiniMed Flex™ on March 18, 2026, a screenless, smartphone‑controlled insulin pump about half the size of the 780G with a 300‑unit reservoir. The pump uses SmartGuard™ with Meal Detection™ and demonstrated 80% Time in Range in real‑world results.

Commercial launch will pair Flex with Simplera Sync™ and Abbott Instinct sensors, begin a select customer phase this spring, and expand broadly in summer. Eligible 780G users can upgrade via the MiniMed™ Forward Program for $0.

Positive

• FDA clearance received on March 18, 2026
• 300‑unit reservoir supports broad insulin needs
• 80% Time in Range demonstrated in real‑world results
• Screenless smartphone control with iOS and Android updates
• Extended infusion set option: up to 7 days wear
• $0 upgrade via MiniMed Forward Program for eligible 780G users

Negative

• Initial commercial availability limited to a select customer phase this spring
• Clearance age limits: ≥7 years for type 1, ≥18 years for insulin‑requiring type 2
• Sensor support at launch limited to Simplera Sync and Abbott Instinct

Argus Mar 18 session

-0.24% close to close Open Argus

Details

News Market Reaction – MMED

On Mar 18, the day this news came out, MMED closed 0.24% below the previous close.

Data tracked by StockTitan Argus for the Mar 18 session.

Key Figures

Insulin reservoir: 300 units Infusion set wear: 7 days Injection reduction: 96% fewer injections +5 more

Insulin reservoir

300 units

Capacity of MiniMed Flex insulin pump

Infusion set wear

7 days

Extended infusion set wear duration

Injection reduction

96% fewer injections

Extended infusion set vs traditional insulin therapy

Time in Range

80%

Real-world AID performance with recommended settings

Upgrade cost

$0

MiniMed Forward Program upgrade from 780G to Flex

Age indication (T1D)

7 years and older

Cleared MiniMed Flex indication for type 1 diabetes

Age indication (T2D)

18 years and older

Cleared MiniMed Flex indication for insulin-requiring type 2 diabetes

IPO shares sold

28,000,000 shares

Initial public offering completed on March 9, 2026

Historical Context

1 past event · Latest: Mar 09

1 event

1. Mar 09

   IPO completion

   24h Move

   +1.8%

   Closed IPO, raised cash with Medtronic retaining majority ownership stake.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fda, infusion set, automated insulin delivery system, ipo

4 terms

fda regulatory

"announced U.S. Food and Drug Administration (FDA) clearance of MiniMed Flex™"

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.

infusion set medical

"Extended infusion set options: Works with MiniMed's infusion set portfolio"

An infusion set is the small medical kit—tube, connector and tiny plastic or soft tube that sits on or under the skin—that delivers drugs or fluids from a pump or IV into a patient’s bloodstream or tissue. For investors it matters because these parts are high-volume, regulated consumables whose reliability, safety and supply affect recurring revenue, product recalls and regulatory risk for companies that make or sell them — like the hose and nozzle for a pump.

automated insulin delivery system medical

"next-generation automated insulin delivery system featuring a small, smartphone-controlled insulin pump"

An automated insulin delivery system is a device that automatically monitors blood sugar levels and adjusts insulin delivery without needing manual input. Think of it as a smart thermostat that keeps a room’s temperature just right, ensuring stable levels. For investors, such systems represent advances in healthcare technology that can improve quality of life and potentially reduce long-term medical costs.

ipo financial

"first product as a standalone, public company — just one week after our IPO"

An initial public offering (IPO) is the process by which a private company sells its shares to the public for the first time, making its ownership available on the stock market. This allows the company to raise money from a wide range of investors to fund growth or other goals. For investors, an IPO offers a chance to buy into a company early in its public journey, potentially benefiting if the company grows in value.

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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.

MiniMed Flex™ represents a major redesign of MiniMed's insulin pumps.

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

1. Arrieta A, et al. Diabetes Obes Metab. 2022;10.1111/dom.14714.
2. 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.
3. 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.

 

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SOURCE MiniMed

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did MiniMed (MMED) announce on March 18, 2026 about MiniMed Flex™?

MiniMed announced FDA clearance of MiniMed Flex™, a screenless, smartphone‑controlled 300‑unit pump. According to MiniMed, Flex uses the SmartGuard™ algorithm with Meal Detection™ and showed 80% Time in Range in real‑world results, with commercial rollout beginning this spring.

How can current MiniMed 780G users upgrade to MiniMed Flex™ (MMED)?

Eligible MiniMed 780G users can upgrade to MiniMed Flex™ through the MiniMed Forward Program for $0. According to MiniMed, new 780G users who enroll will be notified when Flex becomes commercially available and given upgrade instructions.

Which sensors will be compatible with MiniMed Flex™ at commercial launch (MMED)?

At launch, MiniMed Flex™ will support Simplera Sync™ and the Abbott Instinct sensor. According to MiniMed, these sensors comprise the company's newest sensor portfolio and will be supported when the Flex system becomes commercially available.

What are the MiniMed Flex™ age and diagnosis eligibility criteria (MMED)?

MiniMed Flex™ is cleared for individuals aged 7 and older with type 1 diabetes, and 18 and older with insulin‑requiring type 2 diabetes. According to MiniMed, these are the FDA‑cleared age and diagnosis boundaries for the Flex system.

When will MiniMed Flex™ (MMED) become available to customers?

MiniMed Flex™ will enter a select customer experience phase this spring, followed by a broader commercial launch planned for summer. According to MiniMed, the staged rollout is intended to begin with select current customers before wider availability.

What clinical performance did MiniMed report for the Flex™ SmartGuard™ algorithm (MMED)?

Real‑world results demonstrated 80% Time in Range with recommended settings for MiniMed Flex™. According to MiniMed, the SmartGuard™ algorithm with Meal Detection™ achieved this Time in Range performance in real‑world use.