产颈辞惭茅谤颈别耻虫 receives FDA 510(k) Clearance for its VITEK庐 COMPACT PRO, a new ID/AST system to fight against antimicrobial resistance
产颈辞惭茅谤颈别耻虫 (BMXXY) has received FDA 510(k) clearance for VITEK庐 COMPACT PRO, an advanced system for microorganism identification (ID) and antibiotic susceptibility testing (AST). This innovative solution aims to combat antimicrobial resistance and help diagnose infectious diseases in clinical laboratories while also supporting industrial laboratories in identifying contaminants for consumer safety.
The system builds upon its predecessor VITEK庐 2 COMPACT, featuring enhanced ergonomic design and simplified workflow that reduces sample loading and processing time. Targeting small and medium-sized laboratories, VITEK庐 COMPACT PRO offers efficient workflows and rapid ID/AST results.
The commercial launch is scheduled to begin in select countries, followed by a global rollout starting in Q2 2025. The system addresses critical healthcare challenges, considering that 11 million people worldwide die of sepsis annually, with 1.3 million deaths attributed to antibiotic-resistant bacteria.
产颈辞惭茅谤颈别耻虫 (BMXXY) ha ricevuto l'approvazione 510(k) dalla FDA per il VITEK庐 COMPACT PRO, un sistema avanzato per l'identificazione dei microorganismi (ID) e il test di suscettibilit脿 agli antibiotici (AST). Questa soluzione innovativa mira a combattere la resistenza antimicrobica e a contribuire alla diagnosi di malattie infettive nei laboratori clinici, supportando anche i laboratori industriali nell'identificazione di contaminanti per la sicurezza dei consumatori.
Il sistema si basa sul suo predecessore VITEK庐 2 COMPACT, con un design ergonomico migliorato e un flusso di lavoro semplificato che riduce i tempi di caricamento e di elaborazione dei campioni. Rivolto a laboratori di piccole e medie dimensioni, il VITEK庐 COMPACT PRO offre flussi di lavoro efficienti e risultati rapidi per ID/AST.
Il lancio commerciale 猫 previsto in alcuni paesi selezionati, seguito da una diffusione globale a partire dal secondo trimestre del 2025. Il sistema affronta sfide sanitarie critiche, considerando che 11 milioni di persone nel mondo muoiono ogni anno di sepsi, con 1,3 milioni di decessi attribuiti a batteri resistenti agli antibiotici.
产颈辞惭茅谤颈别耻虫 (BMXXY) ha recibido la aprobaci贸n 510(k) de la FDA para el VITEK庐 COMPACT PRO, un sistema avanzado para la identificaci贸n de microorganismos (ID) y pruebas de susceptibilidad a antibi贸ticos (AST). Esta soluci贸n innovadora tiene como objetivo combatir la resistencia antimicrobiana y ayudar a diagnosticar enfermedades infecciosas en laboratorios cl铆nicos, al mismo tiempo que apoya a laboratorios industriales en la identificaci贸n de contaminantes para la seguridad del consumidor.
El sistema se basa en su predecesor VITEK庐 2 COMPACT, con un dise帽o ergon贸mico mejorado y un flujo de trabajo simplificado que reduce el tiempo de carga y procesamiento de muestras. Dirigido a laboratorios peque帽os y medianos, el VITEK庐 COMPACT PRO ofrece flujos de trabajo eficientes y resultados r谩pidos de ID/AST.
El lanzamiento comercial est谩 programado para comenzar en pa铆ses seleccionados, seguido de un despliegue global que comenzar谩 en el segundo trimestre de 2025. El sistema aborda desaf铆os cr铆ticos en salud, considerando que 11 millones de personas en todo el mundo mueren anualmente por sepsis, con 1,3 millones de muertes atribuidas a bacterias resistentes a antibi贸ticos.
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鞚� 鞁滌姢韰滌潃 鞚挫爠 氇嵏鞚� VITEK庐 2 COMPACT毳� 旮半皹鞙茧 頃橂┌, 靸橅攲 搿滊敥 氚� 觳橂Μ 鞁滉皠鞚� 欷勳澊电� 頄レ儊霅� 鞚胳泊瓿淀暀鞝� 霐旍瀽鞚戈臣 臧勳唽頇旊悳 鞛戩梾 頋愲鞚� 韸轨鞙茧 頃╇媹雼�. 靻岅窚氇� 氚� 欷戧窚氇� 鞁ろ棙鞁れ潉 雽�靸侅溂搿� 頃樀鐢 VITEK庐 COMPACT PRO电� 須湪鞝侅澑 鞛戩梾 頋愲瓿� 鞁犾啀頃� ID/AST 瓴瓣臣毳� 鞝滉车頃╇媹雼�.
靸侅梾鞝� 於滌嫓电� 鞚茧秬 靹犾爼霅� 甑皜鞐愳劀 鞁滌瀾霅� 鞓堨爼鞚措┌, 2025雲� 2攵勱赴攵�韯� 旮�搿滊矊 搿れ晞鞗冹澊 鞁滌瀾霅╇媹雼�. 鞚� 鞁滌姢韰滌潃 毵る厔 鞝� 靹戈硠鞐愳劀 1100毵� 氇呾澊 韺槇歃濎溂搿� 靷頃橁碃, 130毵� 氇呾潣 靷鞚� 頃儩鞝� 雮挫劚 氚曧厡毽晞鞐� 旮办澑頃滊嫟电� 鞝愳潉 瓿犽牑頃橃棳 欷戩殧頃� 鞚橂 氍胳牅毳� 雼る９雼堧嫟.
产颈辞惭茅谤颈别耻虫 (BMXXY) a re莽u l'autorisation 510(k) de la FDA pour le VITEK庐 COMPACT PRO, un syst猫me avanc茅 pour l'identification des microorganismes (ID) et le test de sensibilit茅 aux antibiotiques (AST). Cette solution innovante vise 脿 lutter contre la r茅sistance antimicrobienne et 脿 aider au diagnostic des maladies infectieuses dans les laboratoires cliniques, tout en soutenant 茅galement les laboratoires industriels dans l'identification des contaminants pour la s茅curit茅 des consommateurs.
Le syst猫me s'appuie sur son pr茅d茅cesseur VITEK庐 2 COMPACT, avec un design ergonomique am茅lior茅 et un flux de travail simplifi茅 qui r茅duit le temps de chargement et de traitement des 茅chantillons. Destin茅 aux laboratoires de petite et moyenne taille, le VITEK庐 COMPACT PRO offre des flux de travail efficaces et des r茅sultats rapides pour l'ID/AST.
Le lancement commercial est pr茅vu dans certains pays s茅lectionn茅s, suivi d'un d茅ploiement mondial 脿 partir du deuxi猫me trimestre 2025. Le syst猫me r茅pond 脿 des d茅fis critiques en mati猫re de sant茅, sachant que 11 millions de personnes dans le monde meurent chaque ann茅e de sepsie, avec 1,3 million de d茅c猫s attribu茅s 脿 des bact茅ries r茅sistantes aux antibiotiques.
产颈辞惭茅谤颈别耻虫 (BMXXY) hat die FDA 510(k) Zulassung f眉r das VITEK庐 COMPACT PRO erhalten, ein fortschrittliches System zur Identifizierung von Mikroorganismen (ID) und zur Pr眉fung der Antibiotikaempfindlichkeit (AST). Diese innovative L枚sung zielt darauf ab, der antimikrobiellen Resistenz entgegenzuwirken und bei der Diagnose von Infektionskrankheiten in klinischen Laboren zu helfen, w盲hrend sie auch industrielle Labore bei der Identifizierung von Verunreinigungen zur Verbrauchersicherheit unterst眉tzt.
Das System baut auf seinem Vorg盲nger VITEK庐 2 COMPACT auf und bietet ein verbessertes ergonomisches Design sowie einen vereinfachten Arbeitsablauf, der die Probenbeladungs- und Verarbeitungszeit verk眉rzt. Das VITEK庐 COMPACT PRO richtet sich an kleine und mittelgro脽e Labore und bietet effiziente Arbeitsabl盲ufe sowie schnelle ID/AST-Ergebnisse.
Der kommerzielle Start ist in ausgew盲hlten L盲ndern geplant, gefolgt von einer globalen Einf眉hrung, die im 2. Quartal 2025 beginnen soll. Das System adressiert kritische Herausforderungen im Gesundheitswesen, da j盲hrlich weltweit 11 Millionen Menschen an Sepsis sterben, wobei 1,3 Millionen Todesf盲lle auf antibiotikaresistente Bakterien zur眉ckzuf眉hren sind.
- FDA 510(k) clearance received for new diagnostic system
- Improved efficiency with reduced sample loading and processing time
- Expansion into small and medium-sized laboratory market segment
- Dual application for both clinical and industrial use
- None.
MARCY L'脡TOILE,
Every year 11 million people worldwide die of sepsis1 and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria2. Antimicrobial resistance (AMR) continues unabated making detection of resistant pathogens more complex. Clinicians need to receive accurate identification and faster antibiotic susceptibility test (AST) results, to enable timely and optimized patient intervention.
For over 30 years as a global leader in automated ID/AST systems, 产颈辞惭茅谤颈别耻虫 continues to collaborate with laboratory professionals and clinicians to innovate microbiology solutions for improved patient health management, operating cost efficiencies, and effective antimicrobial stewardship (AMS).
VITEK庐 COMPACT PRO combines the latest diagnostic technology with the globally acknowledged advantages of its predecessor: VITEK庐 2 COMPACT. With an ergonomically advanced design and a simplified workflow, it further enhances the user experience and improves overall efficiency as the laboratory technician has to spend less time for sample loading and processing3. It offers one of the most efficient workflows, fastest routine ID/AST results and microbiology expertise for accurate and confident diagnostics听insights4. Ideally suited for small and medium-sized laboratories, VITEK庐 COMPACT PRO will also enable laboratories transitioning from manual workflows to benefit from automation efficiencies.
"For decades, 产颈辞惭茅谤颈别耻虫 has been an industry leader in microbiology innovation. With the introduction of VITEK庐 COMPACT PRO, we are continuing this journey and delivering on the specialized needs of our customers 鈥� supporting laboratories with simplified, efficient workflows and the latest technology to optimize their experience. Through ongoing expansion of our VITEK庐 solutions portfolio, 产颈辞惭茅谤颈别耻虫 continues to strengthen our comprehensive AMR/AMS offer and reinforce our commitment to provide next-generation ID/AST systems to healthcare and laboratory professionals around the world," commented Jennifer Zinn, Executive Vice President, Clinical Operations.
"As a leader in the fight against AMR, 产颈辞惭茅谤颈别耻虫 continuously innovates by developing and renewing its key diagnostic solutions. VITEK庐 COMPACT PRO delivers fast, accurate and reproducible results comparable to VITEK庐 2 and VITEK庐 2 COMPACT systems. The ergonomic features, a new intuitive user interface, and an updated software with one of the most comprehensive knowledge database makes VITEK庐 COMPACT PRO highly appealing to both clinical and industrial laboratories." added C茅line Roger-Dalbert, Executive Vice President, Research and Development.
For industrial applications, VITEK庐听COMPACT PRO will be used for routine identification of pathogens to ensure the quality and safety of food, pharmaceutical, and cosmetic products.
The commercial launch of VITEK庐 COMPACT PRO is initially planned in select countries, followed by global launch starting in the second quarter of 2025.
1听Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet (
2听Murray CJ. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:(21)02724-0.
3 产颈辞惭茅谤颈别耻虫 proprietary data on file: VITEK庐 COMPACT PRO vs. VITEK庐 2 COMPACT
4 Decarli A et al. JMM. 2022; 71:001543; 产颈辞惭茅谤颈别耻虫 proprietary data on file; Rommler W et al. ASM 2006; Poster C-123; Heller-Ono A Seln. of Publications VITEK庐 2: 产颈辞惭茅谤颈别耻虫 White Paper 2008; Lombardi Vincent J, Seln. of Publications VITEK庐 2: bioMerieux White Paper 2011; Hooper M et al. ECCMID 2013; Poster P-1536; Carvalhaes CG et al. ECCMID 2023 Poster # P0384.
ABOUT BIOM脡RIEUX'S COMPLETE ANTIMICROBIAL STEWARDSHIP (AMS) SOLUTION
产颈辞惭茅谤颈别耻虫's healthcare mission is to help sustain the use of antibiotic efficacy for generations to come.
To support hospitals, institutions, and laboratories with their AMS programs, 产颈辞惭茅谤颈别耻虫 has a complete solution covering antibiotic therapy initiation, optimization, and discontinuation. This constantly evolving offer provides timely, accurate results to adjust therapy, transforms data into actionable insights, and integrates smoothly into any hospital with its flexible partnership approach. 产颈辞惭茅谤颈别耻虫 has more than 60 years of microbiology expertise with
ABOUT BIOM脡RIEUX
Pioneering Diagnostics
A world leader in the field of in听vitro diagnostics since 1963, 产颈辞惭茅谤颈别耻虫 is present in 45听countries and serves more than 160听countries with the support of a large network of distributors. In 2024, revenues reached
产颈辞惭茅谤颈别耻虫 provides diagnostic solutions (systems, reagents, software, and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in听food, pharmaceutical and cosmetic products.
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产颈辞惭茅谤颈别耻虫 is listed on the Euronext Paris stock market.
Symbol: BIM 鈥� ISIN Code: FR0013280286
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FAQ
When will 产颈辞惭茅谤颈别耻虫 (BMXXY) launch VITEK COMPACT PRO globally?
What are the key improvements in BMXXY's VITEK COMPACT PRO over its predecessor?
How will VITEK COMPACT PRO benefit clinical laboratories?
What market segments is BMXXY targeting with VITEK COMPACT PRO?
