ICU Medical Introduces Its New Category of Infusion Devices With FDA Clearances of Plum Solo™ and Plum Duo™ Precision IV Pumps
ICU Medical (NASDAQ:ICUI) has received FDA 510(k) clearance for its new Plum Solo™ and updated Plum Duo™ precision IV pumps, along with LifeShield™ infusion safety software. These devices introduce a new category of precision IV pumps designed to address delivery variability with ±3% accuracy in real-world conditions.
The single-channel Plum Solo complements the dual-channel Plum Duo, offering healthcare systems flexibility in device configuration. Both pumps feature compatibility with whole blood and blood products, and include advanced features such as full-color touchscreens, simplified drug library management, and IV-EHR interoperability.
This milestone marks ICU Medical's achievement of 5 FDA 510(k) clearances in the past 18 months, with plans to expand their LifeShield platform with next-generation Medfusion™ syringe pump and CADD™ pain and ambulatory pump products.
ICU Medical (NASDAQ:ICUI) ha ricevuto l'approvazione FDA 510(k) per i suoi nuovi Plum Solo™ e Plum Duo™ aggiornati, insieme al software di sicurezza per infusioni LifeShield™. Questi dispositivi introducono una nuova categoria di pompe IV di precisione progettate per affrontare la variabilità nella somministrazione con un'accuratezza di ±3% in condizioni reali.
La Plum Solo a canale singolo completa la Plum Duo a doppio canale, offrendo ai sistemi sanitari flessibilità nella configurazione dei dispositivi. Entrambe le pompe sono compatibili con sangue intero e prodotti ematici, e includono funzionalità avanzate come touchscreen a colori, gestione semplificata della libreria dei farmaci e interoperabilità IV-EHR.
Questo traguardo segna il raggiungimento da parte di ICU Medical di 5 approvazioni FDA 510(k) negli ultimi 18 mesi, con piani per espandere la loro piattaforma LifeShield con i prodotti per siringhe Medfusion™ di nuova generazione e pompe per il dolore e ambulatoriali CADD™.
ICU Medical (NASDAQ:ICUI) ha recibido la aprobación 510(k) de la FDA para sus nuevas bombas IV de precisión Plum Solo™ y Plum Duo™ actualizadas, junto con el software de seguridad para infusiones LifeShield™. Estos dispositivos introducen una nueva categoría de bombas IV de precisión diseñadas para abordar la variabilidad en la entrega con una precisión de ±3% en condiciones del mundo real.
La Plum Solo de canal único complementa la Plum Duo de doble canal, ofreciendo a los sistemas de salud flexibilidad en la configuración del dispositivo. Ambas bombas son compatibles con sangre completa y productos sanguíneos, e incluyen características avanzadas como pantallas táctiles a color, gestión simplificada de la biblioteca de medicamentos e interoperabilidad IV-EHR.
Este hito marca el logro de ICU Medical de 5 aprobaciones 510(k) de la FDA en los últimos 18 meses, con planes para expandir su plataforma LifeShield con la bomba de jeringa Medfusion™ de próxima generación y productos de bombas de dolor y ambulatorias CADD™.
ICU Medical (NASDAQ:ICUI)는 새로운 Plum Solo™와 업데이트된 Plum Duo™ 정밀 IV 펌프 및 LifeShield™ 주입 안전 소프트웨어에 대해 FDA 510(k) 승인을 받았습니다. 이 장치는 실제 조건에서 ±3%의 정확도로 전달 변동성을 해결하기 위해 설계된 새로운 범주의 정밀 IV 펌프를 도입합니다.
단일 채널 Plum Solo는 이중 채널 Plum Duo를 보완하여 의료 시스템에 장치 구성의 유연성을 제공합니다. 두 펌프 모두 전혈 및 혈액 제품과 호환되며, 컬러 터치스크린, 간소화된 약물 라이브러리 관리 및 IV-EHR 상호 운용성과 같은 고급 기능을 포함합니다.
이번 이정표는 ICU Medical이 지난 18개월 동안 5개의 FDA 510(k) 승인을 달성한 것을 의미하며, 차세대 Medfusion™ 주사기 펌프 및 CADD™ 통증 및 외래 펌프 제품으로 LifeShield 플랫폼을 확장할 계획입니다.
ICU Medical (NASDAQ:ICUI) a reçu l'approbation FDA 510(k) pour ses nouvelles pompes IV de précision Plum Solo™ et Plum Duo™ mises à jour, ainsi que pour le logiciel de sécurité d'infusion LifeShield™. Ces dispositifs introduisent une nouvelle catégorie de pompes IV de précision conçues pour traiter la variabilité de livraison avec une précision de ±3 % dans des conditions réelles.
La Plum Solo à canal unique complète la Plum Duo à double canal, offrant aux systèmes de santé une flexibilité dans la configuration des dispositifs. Les deux pompes sont compatibles avec le sang total et les produits sanguins, et incluent des fonctionnalités avancées telles que des écrans tactiles couleur, une gestion simplifiée de la bibliothèque de médicaments et l'interopérabilité IV-EHR.
Ce jalon marque l'accomplissement d'ICU Medical d'avoir obtenu 5 approbations FDA 510(k) au cours des 18 derniers mois, avec des plans pour étendre leur plateforme LifeShield avec la pompe à seringue Medfusion™ de nouvelle génération et les produits de pompe CADD™ pour la douleur et ambulatoires.
ICU Medical (NASDAQ:ICUI) hat die FDA 510(k)-Zulassung für seine neuen Plum Solo™ und aktualisierten Plum Duo™ Präzisions-IV-Pumpen sowie die LifeShield™ Infusionssicherheitssoftware erhalten. Diese Geräte führen eine neue Kategorie von Präzisions-IV-Pumpen ein, die entwickelt wurden, um die Variabilität der Abgabe mit einer Genauigkeit von ±3 % unter realen Bedingungen zu adressieren.
Die Einzelkanal-Plum Solo ergänzt die Dualkanal-Plum Duo und bietet den Gesundheitssystemen Flexibilität in der Gerätekonfiguration. Beide Pumpen sind mit Vollblut und Blutprodukten kompatibel und verfügen über fortschrittliche Funktionen wie Farbtouchscreens, vereinfachte Verwaltung der Medikamentenbibliothek und IV-EHR-Interoperabilität.
Dieser Meilenstein markiert den Erfolg von ICU Medical, in den letzten 18 Monaten 5 FDA 510(k)-Zulassungen zu erhalten, mit Plänen zur Erweiterung ihrer LifeShield-Plattform mit der nächsten Generation von Medfusion™-Spritzenpumpen und CADD™-Schmerz- und Ambulanzpumpen.
- FDA 510(k) clearance received for new precision IV pump products
- Achievement of 5 FDA clearances in past 18 months shows strong regulatory execution
- Enhanced product portfolio with both single and dual-channel precision pumps
- Superior ±3% accuracy rate in real-world conditions
- Compatibility with whole blood and blood products expands use cases
- None.
Insights
ICU Medical's FDA 510(k) clearances for multiple infusion devices represents a strategically significant portfolio expansion at a crucial time in the medical device market. The simultaneous clearance of the Plum Solo™, updated Plum Duo™, and LifeShield™ software completes their IV Performance Platform, creating an integrated ecosystem rather than just individual products.
This move transforms ICU Medical from a component manufacturer into a platform provider - a far more defensible market position with higher switching costs for customers. The ±3% accuracy specification addresses a significant clinical pain point, as medication delivery precision directly impacts patient outcomes, particularly for critical drugs with narrow therapeutic windows.
The introduction of both single and dual-channel pumps provides flexibility to healthcare systems trying to optimize their device fleet while maintaining standardization. This platform approach mirrors successful strategies from companies like Medtronic and Edwards Lifesciences, where ecosystem compatibility drives customer retention.
With five FDA clearances in 18 months, ICU Medical is executing an accelerated regulatory strategy that positions them to capture market share while competitors may be struggling with submission backlogs. The timing aligns with healthcare systems' increasing focus on data integrity across care settings, making infusion accuracy data a potential competitive differentiator.
The strategic roadmap to incorporate Medfusion™ syringe pumps and CADD™ ambulatory pumps further expands addressable markets and creates cross-selling opportunities across their portfolio, potentially driving revenue growth beyond just the initial pump sales.
ICU Medical's new precision IV pumps address a fundamental challenge in medication delivery that has persisted for decades - the variability between programmed and actual delivered doses. Traditional pump technologies rely on specific setup conditions that rarely match real-world clinical environments, leading to documented delivery inaccuracies that can impact patient care.
The cassette technology underlying both the Plum Solo™ and Duo™ eliminates common variables that affect accuracy - pump height relative to the patient, back pressure, temperature fluctuations, and elevation differences. This is particularly critical for medications where precise dosing is essential - vasopressors, insulin, chemotherapy agents, and anesthetics.
The compatibility with whole blood and blood products addresses another significant clinical limitation of many infusion devices, eliminating the need for dedicated blood pumps and simplifying workflow for clinicians managing complex patient needs.
The full-color touchscreens (7-inch Solo, 10-inch Duo) align with modern clinical usability expectations while the reduced cognitive load is particularly valuable given the documented relationship between pump programming complexity and medication errors.
Perhaps most important is the IV-EHR interoperability built on 16 years of connectivity experience. As healthcare systems struggle with fragmented device data landscapes, ICU Medical's harmonized IT platform offers smoother integration into clinical documentation workflows, supporting closed-loop medication management and comprehensive analysis of medication delivery patterns that could enhance both safety and efficiency.
New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform.
Unlike traditional pumps that rely on specific setups and conditions for accurate delivery, precision IV pumps are designed to address delivery variability while supporting the increasing need for accurate data in modern patient care. Built on the unique cassette technology in the Best in KLAS award-winning Plum 360™, the Plum Solo and Plum Duo precision IV pumps deliver ±
"Precision IV pumps represent a critical step forward for infusion therapy," said Chad Jansen, corporate vice president and general manager of ICU Medical Infusion Systems. "With the Plum Solo and Plum Duo, we're introducing more than just a new device category—we're setting a new standard. Healthcare teams can now trust not only the delivery of their medications but also the infusion data that supports their decisions, knowing it reflects what patients actually receive."
The Plum Solo expands the capabilities of the IV Performance Platform by offering a single-channel pump designed to work alongside the dual-channel Plum Duo—recently recognized in a KLAS Emerging Insights Report with emerging data showing an A+ rating for new technology, likely to recommend, and money's worth.
Together, Plum Solo and Plum Duo provide healthcare systems with the flexibility to choose the right configuration for their infusion needs, optimizing device footprint without compromising performance or safety. Both devices are compatible with whole blood and blood products and deliver consistent ±
- Precise Delivery: Unique pumping mechanism allowing for accurate and precise medication delivery—including whole blood and blood products—with both Plum Solo and Plum Duo pumps, no matter where the pump or the infusion bag is placed.
- Simplified User Experience: Full-color touchscreens (7-inch on Plum Solo, 10-inch on Plum Duo) deliver intuitive programming with near real-time safety feedback for faster workflows and reduced cognitive load.
- Streamlined Medication Management: Simplified drug library and firmware deployment, managed from a central location anytime, anywhere, to help ensure devices are consistently updated and pumps are on the most current software version.
- Full IV-EHR Interoperability: Built on ICU Medical's 16 years of industry-leading experience, LifeShield software connectivity and integration can support better decision-making and more coordinated care across healthcare systems.
- Future Ready: The LifeShield enterprise ecosystem will provide a single, harmonized IT platform for ICU Medical's road map of delivering best-of-breed devices for every infusion modality.
"We are proud of this milestone, but this is just the next step in creating the most comprehensive, precise, and technologically advanced infusion platform," Jansen said. "This milestone delivers on our promised roadmap with 5 products receiving FDA 510(k) clearance in the past 18 months. We look forward to bringing our next-generation MedfusionTM syringe pump and CADDTM pain and ambulatory pump products to the LifeShield platform. This is the future of infusion therapy, and we're proud to be leading the way."
Media Contact:
Harrison Richards
ICU Medical, Inc.
949-366-4261
Harrison.Richards@icumed.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/icu-medical-introduces-its-new-category-of-infusion-devices-with-fda-clearances-of-plum-solo-and-plum-duo-precision-iv-pumps-302421156.html
SOURCE ICU Medical, Inc.
FAQ
What accuracy rate do ICU Medical's new Plum Solo and Plum Duo IV pumps deliver?
How many FDA clearances has ICU Medical (ICUI) received in the past 18 months?
What are the key differences between Plum Solo and Plum Duo IV pumps?
What products is ICU Medical planning to add to their LifeShield platform?
What capabilities does ICU Medical's LifeShield software provide?
