IRADIMED CORPORATION Announces FDA 510(k) Clearance for MRidium® 3870 Infusion Pump System
Iradimed Corporation (NASDAQ: IRMD) has received FDA 510(k) clearance for its MRidium® 3870 IV Infusion Pump System, a next-generation MRI-compatible infusion pump. The device maintains Iradimed's unique position as the world's only provider of non-magnetic MRI infusion pumps since 2005. The new system features a non-magnetic ultrasonic pump motor, non-interfering RF emissions, and an enhanced touchscreen interface.
Key features include the ability to operate independently or as a four-channel system, and a modern drug library solution supporting multiple patient care areas. The company plans to begin deployment to select healthcare facilities in Q4 2025, with full commercial distribution ramping throughout 2026.
Iradimed Corporation (NASDAQ: IRMD) ha ottenuto l'autorizzazione FDA 510(k) per il suo MRidium® 3870 IV Infusion Pump System, una pompa per infusione compatibile con la risonanza magnetica di nuova generazione. Il dispositivo conferma la posizione unica di Iradimed come unico fornitore al mondo di pompe per infusione non magnetiche per MRI dal 2005. Il nuovo sistema è dotato di un motore a ultrasuoni non magnetico, emissioni RF non interferenti e un'interfaccia touchscreen migliorata.
Le caratteristiche principali includono la capacità di funzionare in modo indipendente o come sistema a quattro canali, e una moderna soluzione di libreria farmaci che supporta diverse aree di assistenza ai pazienti. L'azienda prevede di iniziare la distribuzione in alcune strutture sanitarie selezionate nel quarto trimestre del 2025, con un'espansione commerciale completa prevista per il 2026.
Iradimed Corporation (NASDAQ: IRMD) ha recibido la aprobación FDA 510(k) para su MRidium® 3870 IV Infusion Pump System, una bomba de infusión compatible con MRI de próxima generación. El dispositivo mantiene la posición única de Iradimed como el único proveedor mundial de bombas de infusión no magnéticas para MRI desde 2005. El nuevo sistema cuenta con un motor ultrasónico no magnético, emisiones RF que no interfieren y una interfaz táctil mejorada.
Las características clave incluyen la capacidad de operar de forma independiente o como un sistema de cuatro canales, y una moderna solución de biblioteca de medicamentos que soporta múltiples áreas de atención al paciente. La compañía planea comenzar la implementación en centros de salud selectos en el cuarto trimestre de 2025, con una distribución comercial completa durante 2026.
Iradimed Corporation (NASDAQ: IRMD)는 차세대 MRI 호환 주입 펌프인 MRidium® 3870 IV Infusion Pump System에 대해 FDA 510(k) 승인을 받았습니다. 이 장치는 2005년부터 비자기 MRI 주입 펌프를 제공하는 세계 유일의 업체로서 Iradimed의 독특한 위치를 유지합니다. 새 시스템은 비자기 초음파 펌프 모터, 간섭 없는 RF 방출, 향상된 터치스크린 인터페이스를 특징으로 합니다.
주요 기능으로는 독립 작동 또는 4채널 시스템으로의 운영 가능, 그리고 여러 환자 치료 영역을 지원하는 최신 약물 라이브러리 솔루션이 포함됩니다. 회사는 2025년 4분기에 일부 의료 시설에 배포를 시작하고, 2026년 전반에 걸쳐 상업적 유통을 확대할 계획입니다.
Iradimed Corporation (NASDAQ: IRMD) a obtenu l'autorisation FDA 510(k) pour son MRidium® 3870 IV Infusion Pump System, une pompe à perfusion compatible IRM de nouvelle génération. Cet appareil confirme la position unique d'Iradimed en tant que seul fournisseur mondial de pompes à perfusion non magnétiques pour IRM depuis 2005. Le nouveau système est équipé d'un moteur à ultrasons non magnétique, d'émissions RF non perturbatrices et d'une interface tactile améliorée.
Les caractéristiques clés incluent la capacité de fonctionner de manière autonome ou en système à quatre canaux, ainsi qu'une solution moderne de bibliothèque de médicaments supportant plusieurs domaines de soins aux patients. L'entreprise prévoit de commencer le déploiement dans certains établissements de santé sélectionnés au quatrième trimestre 2025, avec une distribution commerciale complète prévue en 2026.
Iradimed Corporation (NASDAQ: IRMD) hat die FDA 510(k)-Zulassung für sein MRidium® 3870 IV Infusion Pump System erhalten, eine Infusionspumpe der nächsten Generation, die mit MRI kompatibel ist. Das Gerät festigt Iradimeds einzigartige Position als weltweit einziger Anbieter nicht-magnetischer MRI-Infusionspumpen seit 2005. Das neue System verfügt über einen nicht-magnetischen Ultraschallpumpenmotor, nicht störende RF-Emissionen und eine verbesserte Touchscreen-Oberfläche.
Zu den Hauptmerkmalen gehören die Möglichkeit, unabhängig oder als Vier-Kanal-System zu arbeiten, sowie eine moderne Medikamentenbibliothek, die mehrere Patientenversorgungsbereiche unterstützt. Das Unternehmen plant, die Einführung in ausgewählten Gesundheitseinrichtungen im 4. Quartal 2025 zu starten, mit einer vollständigen kommerziellen Distribution im Verlauf des Jahres 2026.
- FDA 510(k) clearance received for next-generation MRidium® 3870 IV Infusion Pump System
- Maintains unique market position as world's only supplier of non-magnetic MRI infusion pumps
- Enhanced capabilities including four-channel operation and modern drug library solution
- Strategic rollout planned for Q4 2025 with full commercial distribution in 2026
- None.
Insights
FDA clearance of Iradimed's new MRI-compatible infusion pump strengthens market leadership and enables commercialization starting Q4 2025.
The FDA 510(k) clearance for Iradimed's MRidium® 3870 Infusion Pump System represents a significant regulatory milestone that validates the company's specialized technology for MRI environments. This clearance reinforces Iradimed's unique market position as the world's only supplier of non-magnetic MRI infusion pumps, a niche they've dominated since 2005.
The technical advancements in this next-generation system are substantial. The device features a non-magnetic ultrasonic pump motor, non-interfering RF emissions, and non-ferrous components - critical elements for safe operation in high-magnetic-field environments. The enhanced touchscreen interface and ability to function as a four-channel system represent meaningful improvements over previous models.
From a regulatory perspective, the mention of "productive collaboration with the FDA to meet evolving and stringent regulatory requirements" suggests this clearance process was rigorous, which potentially creates a higher barrier to entry for competitors. The modern drug library solution with multiple patient care area listings indicates the device meets complex clinical requirements across various healthcare settings.
The commercial rollout strategy is measured, with initial deployments in Q4 2025 followed by ramped distribution throughout 2026. This phased approach suggests careful production scaling and targeted initial placements to gather real-world feedback before full-scale commercialization.
For Iradimed, this clearance enables them to refresh their product line and potentially expand their addressable market, particularly as MRI usage continues to grow in healthcare. The timing of full commercialization in 2026 means significant revenue impact will likely be delayed until that period.
WINTER SPRINGS, Fla., May 29, 2025 (GLOBE NEWSWIRE) -- Iradimed Corporation (NASDAQ: IRMD), a global leader in innovative medical devices for MRI environments, today 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. This advanced, MRI-compatible infusion pump extends Iradimed’s unique position as the world’s only supplier of non-magnetic MRI infusion pump devices, established with our first-generation device in 2005.
The MRidium® 3870 is poised to strengthen Iradimed’s leadership for MRI-compatible infusion, addressing growing demands for safe and reliable fluid delivery in diagnostic imaging. The MRidium® 3870 features a non-magnetic ultrasonic pump motor, non-interfering RF emissions, and non-ferrous components, ensuring seamless performance in high-magnetic-field environments. Building on Iradimed’s legacy of innovation, this next-generation system introduces an enhanced, intuitive graphical touchscreen user interface and advanced safety features. The 3870 can operate independently or be combined with additional 3870 pumps to operate as a four-channel IV infusion pump system for critical care patients. The 3870 also features a modern drug library solution that accommodates multiple patient care area drug listing, facilitating use in a wide variety of MRI applications and patient needs. These 3870 enhancements address the evolving needs of healthcare providers, driving patient safety and workflow efficiency during MRI scans.
“We are thrilled to receive FDA 510(k) clearance for the MRidium® 3870, a milestone that underscores our commitment to advancing MRI-compatible medical technology,” said Roger Susi, President and CEO of Iradimed Corporation. “This long-awaited clearance reflects our productive collaboration with the FDA to meet evolving and stringent regulatory requirements. The MRidium® 3870 empowers clinicians to deliver critical IV fluids and medications safely and predictably in MRI environments, improving patient outcomes and operational efficiency.”
Iradimed plans a strategic rollout of the newly FDA-cleared MRidium® 3870 infusion pump with initial unit deployment to select healthcare facilities in the fourth quarter of 2025. Material shipments growing towards full commercial distribution will ramp throughout 2026.
About IRADIMED CORPORATION
IRADIMED CORPORATION is a leader in developing innovative Magnetic Resonance Imaging (“MRI”) compatible medical devices. We design, manufacture, market, and distribute MRI-compatible medical devices, accessories, disposables, and related services.
We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system specifically designed to be safe for use during MRI procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components that can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system. Our patented MRidium® MRI-compatible IV infusion pump system has a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts, and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. Our pump solution provides a seamless approach that enables accurate, safe, and dependable fluid delivery before, during, and after an MRI scan, which is essential to critically ill patients who cannot be removed from their vital medications and children and infants who must generally be sedated to remain immobile during an MRI scan.
Our 3880 MRI-compatible patient vital signs monitoring system has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The Iradimed 3880 system operates dependably in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room. The Iradimed 3880 has a compact, lightweight design, allowing it to travel with the patient from the critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units. The features of the Iradimed 3880 include wireless ECG with dynamic gradient filtering; wireless SpO2 using Masimo® algorithms; non-magnetic respiratory CO2; invasive and non-invasive blood pressure; patient temperature, and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements. The Iradimed 3880 MRI-compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.
For more information, please visit www.iradimed.com.
Forward-Looking Statements
This release and any oral statements made regarding the subject of this release contain forward-looking statements as defined under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, that address activities that the Company assumes, plans, expects, believes, intends, projects, indicates, estimates or anticipates (and other similar expressions) will, should, or may occur in the future are forward-looking statements. The forward-looking statements are based on management’s current belief, based on currently available information, as to the outcome and timing of future events. The forward-looking statements involve risks and uncertainties, including, among others, that our business plans may change as circumstances warrant.
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Such forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside of the Company’s control that could cause actual results to differ materially from the results discussed in the forward-looking statements. These risks, uncertainties, assumptions and other important factors include, but are not limited to, those included in Part II, Item 1A, “Risk Factors” of the Company’s Quarterly Reports on Form 10-Q, and Part I, Item 1A, “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as those otherwise described or updated from time to time in our other filings with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact:
IRADIMED CORPORATION
Jack Glenn
(407) 677-8022
InvestorRelations@iradimed.com
FAQ
What is the significance of FDA 510(k) clearance for IRMD's MRidium 3870 Infusion Pump?
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