iRadimed (IRMD) FDA Approvals $84.22 -0.11 (-0.12%) As of 02:56 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsDividendEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock iRadimed's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by iRadimed (IRMD). Over the past two years, iRadimed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MRidium®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. MRidium® 3870 FDA Regulatory Events MRidium® 3870 is a drug developed by iRadimed for the following indication: MRI infusion pump devices. 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 - May 29,2025Fda Clearance Drug: MRidium® 3870Announced Date: May 29, 2025Indication: MRI infusion pump devicesAnnouncementIradimed Corporation announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System.AI SummaryIradimed Corporation has announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System. The new pump is designed specifically for use in MRI environments and ensures safe fluid delivery during imaging procedures. It features a non-magnetic ultrasonic pump motor along with other non-ferrous components to work reliably within high magnetic fields. An intuitive touchscreen interface and advanced safety features make the device user-friendly and perfect for critical care settings, where it can operate as a single unit or be synchronized with additional pumps to create a multi-channel system. This clearance confirms that the MRidium® 3870 meets strict safety and performance standards. The FDA approval marks a significant step forward for Iradimed as it continues to lead in MRI-compatible medical devices, promising improved patient safety and enhanced workflow efficiency in healthcare facilities.Read Announcement iRadimed FDA Events - Frequently Asked Questions Has iRadimed received FDA approval? As of now, iRadimed (IRMD) has not received any FDA approvals for its therapy in the last two years. What drugs has iRadimed submitted to the FDA? In the past two years, iRadimed (IRMD) has reported FDA regulatory activity for MRidium® 3870. What is the most recent FDA event for iRadimed? The most recent FDA-related event for iRadimed occurred on May 29, 2025, involving MRidium® 3870. The update was categorized as "FDA Clearance," with the company reporting: "Iradimed Corporation announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System." What conditions do iRadimed's current drugs treat? Currently, iRadimed has one therapy (MRidium® 3870) targeting the following condition: MRI infusion pump devices. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agios Pharmaceuticals FDA EventsAgenus FDA EventsArvinas FDA EventsBridgeBio Pharma FDA EventsBriacell Therap FDA EventsBeam Therapeutics FDA EventsCellectis FDA EventsCaribou Biosciences FDA EventsDare Bioscience FDA EventsDefinium Therapeutics FDA EventsGeron FDA EventsMiNK Therapeutics FDA EventsIncannex Healthcare FDA EventsKura Oncology FDA EventsOrchestra BioMed 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 Liquidia FDA Events TransMedics Group FDA Events MiniMed Group FDA Events Soleno Therapeutics FDA Events AxoGen FDA Events NovoCure FDA Events Artivion FDA Events PROCEPT BioRobotics FDA Events Inspire Medical Systems FDA Events Pulse Biosciences FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:IRMD last updated on 6/19/2025 by MarketBeat.com Staff. 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FDA Clearance - May 29,2025Fda Clearance Drug: MRidium® 3870Announced Date: May 29, 2025Indication: MRI infusion pump devicesAnnouncementIradimed Corporation announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System.AI SummaryIradimed Corporation has announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System. The new pump is designed specifically for use in MRI environments and ensures safe fluid delivery during imaging procedures. It features a non-magnetic ultrasonic pump motor along with other non-ferrous components to work reliably within high magnetic fields. An intuitive touchscreen interface and advanced safety features make the device user-friendly and perfect for critical care settings, where it can operate as a single unit or be synchronized with additional pumps to create a multi-channel system. This clearance confirms that the MRidium® 3870 meets strict safety and performance standards. The FDA approval marks a significant step forward for Iradimed as it continues to lead in MRI-compatible medical devices, promising improved patient safety and enhanced workflow efficiency in healthcare facilities.Read Announcement
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