Merit Medical Systems (MMSI) FDA Approvals $69.39 +0.05 (+0.07%) As of 03:29 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Merit Medical Systems' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Merit Medical Systems (MMSI). Over the past two years, Merit Medical Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as WRAPSODY. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. WRAPSODY FDA Regulatory Events WRAPSODY is a drug developed by Merit Medical Systems for the following indication: Cell-Impermeable Endoprosthesis (CIE). 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. Enrollment Update - August 18,2025Enrollment Update Drug: WRAPSODYAnnounced Date: August 18, 2025Indication: Cell-Impermeable Endoprosthesis (CIE).AnnouncementMerit Medical Systems announced today the successful enrollment of the first patient in the WRAP North America registry.AI SummaryMerit Medical Systems announced the first patient enrollment in its WRAP North America registry. The study will gather safety and effectiveness data on the WRAPSODY CIE, which restores vascular access in hemodialysis patients with vein narrowing or blockage. Enrollment began at Bluff City Vascular in Memphis. The registry aims to enroll up to 250 patients in the U.S. and Canada, tracking outcomes over three years after treatment with the WRAPSODY CIE. Omar Davis, MD, Medical Director at Bluff City Vascular, said the registry offers a key opportunity to assess the device’s potential to optimize dialysis care. David J. Dexter II, MD, National Principal Investigator, said evaluating the WRAPSODY CIE’s performance will guide its broader clinical use. Merit CEO Fred P. Lampropoulos called the first enrollment an important step in building robust evidence and advancing technology to improve dialysis care.Read Announcement Merit Medical Systems FDA Events - Frequently Asked Questions Has Merit Medical Systems received FDA approval? As of now, Merit Medical Systems (MMSI) has not received any FDA approvals for its therapy in the last two years. What drugs has Merit Medical Systems submitted to the FDA? In the past two years, Merit Medical Systems (MMSI) has reported FDA regulatory activity for WRAPSODY. What is the most recent FDA event for Merit Medical Systems? The most recent FDA-related event for Merit Medical Systems occurred on August 18, 2025, involving WRAPSODY. The update was categorized as "Enrollment Update," with the company reporting: "Merit Medical Systems announced today the successful enrollment of the first patient in the WRAP North America registry." What conditions do Merit Medical Systems' current drugs treat? Currently, Merit Medical Systems has one therapy (WRAPSODY) targeting the following condition: Cell-Impermeable Endoprosthesis (CIE).. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Artelo Biosciences FDA EventsBiogen FDA EventsNLS Pharmaceutics FDA EventsAC Immune FDA EventsAptevo Therapeutics FDA EventsHeartBeam FDA EventsCandel Therapeutics FDA EventsCogent Biosciences FDA EventsDesign Therapeutics FDA EventsMoleculin Biotech FDA EventsNovoCure FDA EventsSCYNEXIS FDA EventsSarepta Therapeutics FDA EventsStoke Therapeutics FDA EventsVistaGen 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 Align Technology FDA Events Haemonetics FDA Events QuidelOrtho FDA Events Cerus FDA Events Anika Therapeutics FDA Events Cardinal Health FDA Events Becton, Dickinson and Company FDA Events Neurocrine Biosciences FDA Events Genmab A/S FDA Events Ascendis Pharma A/S FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MMSI last updated on 8/19/2025 by MarketBeat.com Staff. 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Enrollment Update - August 18,2025Enrollment Update Drug: WRAPSODYAnnounced Date: August 18, 2025Indication: Cell-Impermeable Endoprosthesis (CIE).AnnouncementMerit Medical Systems announced today the successful enrollment of the first patient in the WRAP North America registry.AI SummaryMerit Medical Systems announced the first patient enrollment in its WRAP North America registry. The study will gather safety and effectiveness data on the WRAPSODY CIE, which restores vascular access in hemodialysis patients with vein narrowing or blockage. Enrollment began at Bluff City Vascular in Memphis. The registry aims to enroll up to 250 patients in the U.S. and Canada, tracking outcomes over three years after treatment with the WRAPSODY CIE. Omar Davis, MD, Medical Director at Bluff City Vascular, said the registry offers a key opportunity to assess the device’s potential to optimize dialysis care. David J. Dexter II, MD, National Principal Investigator, said evaluating the WRAPSODY CIE’s performance will guide its broader clinical use. Merit CEO Fred P. Lampropoulos called the first enrollment an important step in building robust evidence and advancing technology to improve dialysis care.Read Announcement
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