MiniMed Group (MMED) FDA Approvals $10.89 +0.01 (+0.09%) Closing price 05/19/2026 04:00 PM EasternExtended Trading$10.90 +0.00 (+0.05%) As of 05/19/2026 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsFDA EventsHeadlinesSEC FilingsShort InterestTrendsBuy This Stock MiniMed Group's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by MiniMed Group (MMED). Over the past two years, MiniMed Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MiniMed. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. MiniMed Flex FDA Regulatory Events MiniMed Flex is a drug developed by MiniMed Group for the following indication: smartphone-controlled insulin pump. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. FDA Clearance - March 18,2026Fda Clearance Drug: MiniMed FlexAnnounced Date: March 18, 2026Indication: smartphone-controlled insulin pumpAnnouncementMiniMed 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.AI SummaryMiniMed 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 prior MiniMed 780G, Flex represents a major redesign of MiniMed pumps. It includes the SmartGuard™ adaptive algorithm, which automatically adjusts and autocorrects insulin delivery in real time to help keep blood glucose in range. MiniMed Flex™ is cleared for people ages 7 and older with type 1 diabetes and for adults 18 and older with insulin-requiring type 2 diabetes. The launch begins with a customer experience phase this spring for select current MiniMed users, followed by a broader commercial rollout planned for summer. At commercial launch, the system will support MiniMed’s newest sensor portfolio, including the Simplera Sync™ sensor and Abbott’s Instinct sensor.Read Announcement MiniMed Group FDA Events - Frequently Asked Questions Has MiniMed Group received FDA approval? As of now, MiniMed Group (MMED) has not received any FDA approvals for its therapy in the last two years. What drugs has MiniMed Group submitted to the FDA? In the past two years, MiniMed Group (MMED) has reported FDA regulatory activity for MiniMed Flex. What is the most recent FDA event for MiniMed Group? The most recent FDA-related event for MiniMed Group occurred on March 18, 2026, involving MiniMed Flex. The update was categorized as "FDA Clearance," with the company reporting: "MiniMed 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." What conditions do MiniMed Group's current drugs treat? Currently, MiniMed Group has one therapy (MiniMed Flex) targeting the following condition: smartphone-controlled insulin pump. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Alterity Therapeutics FDA EventsBlack Diamond Therapeutics FDA EventsJaguar Animal Health FDA EventsLipocine FDA EventsLantern Pharma FDA EventsZenas BioPharma FDA EventsMerck & Co., Inc. FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Glaukos FDA Events Liquidia FDA Events Soleno Therapeutics FDA Events TransMedics Group FDA Events AxoGen FDA Events NovoCure FDA Events PROCEPT BioRobotics FDA Events Pulse Biosciences FDA Events Inspire Medical Systems FDA Events Artivion FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MMED last updated on 3/18/2026 by MarketBeat.com Staff. 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FDA Clearance - March 18,2026Fda Clearance Drug: MiniMed FlexAnnounced Date: March 18, 2026Indication: smartphone-controlled insulin pumpAnnouncementMiniMed 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.AI SummaryMiniMed 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 prior MiniMed 780G, Flex represents a major redesign of MiniMed pumps. It includes the SmartGuard™ adaptive algorithm, which automatically adjusts and autocorrects insulin delivery in real time to help keep blood glucose in range. MiniMed Flex™ is cleared for people ages 7 and older with type 1 diabetes and for adults 18 and older with insulin-requiring type 2 diabetes. The launch begins with a customer experience phase this spring for select current MiniMed users, followed by a broader commercial rollout planned for summer. At commercial launch, the system will support MiniMed’s newest sensor portfolio, including the Simplera Sync™ sensor and Abbott’s Instinct sensor.Read Announcement
