Roche's momentum in digital pathology continues with FDA clearance on its high-volume slide scanner
Roche (RHHBY) has received additional FDA 510(k) clearance for its VENTANA DP 600 slide scanner, expanding its Digital Pathology Dx system capabilities. This high-capacity scanner can process 240 slides and produces high-resolution digital images of stained tissue samples, representing a significant upgrade with 40 times the capacity of the previously cleared VENTANA DP 200 model.
The system, which received its initial FDA clearance on June 14, 2024, aids pathologists in reviewing and interpreting digital images from formalin-fixed paraffin-embedded (FFPE) tissue for patient diagnosis. The complete Roche Digital Pathology Dx system now includes both the DP 200 and DP 600 scanners, workflow software, and a display, enhancing diagnostic accuracy, consistency, and speed through advanced analysis tools.
Roche (RHHBY) ha ricevuto un ulteriore nulla osta FDA 510(k) per il suo scanner VENTANA DP 600, ampliando le capacit脿 del suo sistema di Diagnosi in Patologia Digitale. Questo scanner ad alta capacit脿 pu貌 elaborare 240 vetrini e produce immagini digitali ad alta risoluzione di campioni tissutali colorati, rappresentando un significativo aggiornamento con una capacit脿 40 volte superiore rispetto al modello precedentemente autorizzato VENTANA DP 200.
Il sistema, che ha ricevuto la sua approvazione iniziale dalla FDA il 14 giugno 2024, aiuta i patologi nella revisione e interpretazione delle immagini digitali derivanti da tessuti fissati in formalina e inclusi in paraffina (FFPE) per la diagnosi dei pazienti. Il sistema completo di Diagnosi in Patologia Digitale Roche include ora sia gli scanner DP 200 che DP 600, software di gestione del flusso di lavoro e un display, migliorando l'accuratezza, la coerenza e la velocit脿 diagnostica attraverso strumenti avanzati di analisi.
Roche (RHHBY) ha recibido una nueva autorizaci贸n FDA 510(k) para su esc谩ner VENTANA DP 600, ampliando las capacidades de su sistema de Diagn贸stico en Patolog铆a Digital. Este esc谩ner de alta capacidad puede procesar 240 portaobjetos y produce im谩genes digitales de alta resoluci贸n de muestras de tejido te帽idas, lo que representa una mejora significativa con 40 veces la capacidad del modelo previamente autorizado VENTANA DP 200.
El sistema, que recibi贸 su autorizaci贸n inicial de la FDA el 14 de junio de 2024, ayuda a los pat贸logos a revisar e interpretar im谩genes digitales de tejidos fijados en formalina e incrustados en parafina (FFPE) para el diagn贸stico de pacientes. El sistema completo de Diagn贸stico en Patolog铆a Digital de Roche ahora incluye tanto los esc谩neres DP 200 como DP 600, software de flujo de trabajo y una pantalla, mejorando la precisi贸n diagn贸stica, la consistencia y la velocidad a trav茅s de herramientas avanzadas de an谩lisis.
搿涤妶(搁贬贬叠驰)电� VENTANA DP 600 鞀澕鞚措摐 鞀れ簮雱�鞐� 雽�頃� 於旉皜 FDA 510(k) 鞀轨澑鞚� 氚涭晞 霐旍韯� 氤戨Μ 歆勲嫧 鞁滌姢韰滌潣 旮半姤鞚� 頇曥灔頄堨姷雼堧嫟. 鞚� 瓿犾毄霟� 鞀れ簮雱埖鐢 240臧滌潣 鞀澕鞚措摐毳� 觳橂Μ頃� 靾� 鞛堨溂氅�, 鞐检儔霅� 臁办 靸橅攲鞚� 瓿犿暣靸侂弰 霐旍韯� 鞚措歆�毳� 靸濎劚頃╇媹雼�. 鞚吹鐢 鞚挫爠鞐� 鞀轨澑霅� VENTANA DP 200 氇嵏鞚� 鞖╇焿鞚� 40氚办潣 靹彪姤 頄レ儊鞚� 鞚橂頃╇媹雼�.
鞚� 鞁滌姢韰滌潃 2024雲� 6鞗� 14鞚检棎 斓滌磮 FDA 鞀轨澑鞚� 氚涭晿鞙茧┌, 氤戨Μ頃欖瀽霌れ澊 韽ゴ毵愲Π鞐� 瓿犾爼霅� 韺岆澕頃� 韽暔 臁办(FFPE)鞚� 霐旍韯� 鞚措歆�毳� 瓴�韱犿晿瓿� 頃挫劃頃樀鐢 雿� 霃勳泙鞚� 欷嶋媹雼�. 搿滌妶鞚� 霐旍韯� 氤戨Μ 歆勲嫧 鞁滌姢韰滌潃 鞚挫牅 DP 200瓿� DP 600 鞀れ簮雱�, 鞗岉伂頂岆 靻岉攧韸胳洦鞏� 氚� 霐旍姢頂岆爤鞚措ゼ 韽暔頃橃棳, 瓿犼笁 攵勳劃 霃勱惮毳� 韱淀暣 歆勲嫧鞚� 鞝曧檿靹�, 鞚缄磤靹� 氚� 靻嶋弰毳� 頄レ儊鞁滍偟雼堧嫟.
Roche (RHHBY) a re莽u une autorisation suppl茅mentaire FDA 510(k) pour son scanner VENTANA DP 600, 茅largissant ainsi les capacit茅s de son syst猫me de diagnostic en pathologie num茅rique. Cet scanner 脿 haute capacit茅 peut traiter 240 lames et produit des images num茅riques haute r茅solution d'茅chantillons de tissus color茅s, repr茅sentant une am茅lioration significative avec une capacit茅 40 fois plus grande que le mod猫le VENTANA DP 200 pr茅c茅demment autoris茅.
Le syst猫me, qui a re莽u son approbation initiale de la FDA le 14 juin 2024, aide les pathologistes 脿 examiner et interpr茅ter des images num茅riques de tissus fix茅s au formol et inclus dans de la paraffine (FFPE) pour le diagnostic des patients. Le syst猫me complet de diagnostic en pathologie num茅rique de Roche comprend d茅sormais les scanners DP 200 et DP 600, des logiciels de flux de travail et un 茅cran, am茅liorant la pr茅cision, la coh茅rence et la rapidit茅 des diagnostics gr芒ce 脿 des outils d'analyse avanc茅s.
Roche (RHHBY) hat eine zus盲tzliche FDA 510(k) Genehmigung f眉r seinen VENTANA DP 600 Folien-Scanner erhalten und erweitert damit die Funktionen seines digitalen Pathologie-Diagnosesystems. Dieser Hochleistungsscanner kann 240 Folien verarbeiten und erzeugt hochaufl枚sende digitale Bilder von gef盲rbten Gewebeproben, was ein bedeutendes Upgrade mit einer 40-fachen Kapazit盲t im Vergleich zum zuvor genehmigten Modell VENTANA DP 200 darstellt.
Das System, das am 14. Juni 2024 die urspr眉ngliche FDA-Zulassung erhielt, unterst眉tzt Pathologen bei der 脺berpr眉fung und Interpretation digitaler Bilder von formalinfixierten, paraffineingebetteten (FFPE) Geweben zur Diagnostik von Patienten. Das vollst盲ndige digitale Pathologie-Diagnosesystem von Roche umfasst jetzt sowohl die DP 200- als auch die DP 600-Scanner, Workflow-Software und ein Display, was die diagnostische Genauigkeit, Konsistenz und Geschwindigkeit durch fortschrittliche Analysetools verbessert.
- FDA clearance received for high-capacity VENTANA DP 600 scanner
- 40x increased capacity compared to previous model (240 slides)
- Enhanced diagnostic capabilities through high-resolution digital imaging
- Expanded product portfolio in digital pathology segment
- None.
- The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images.
- This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab.
- Primary diagnosis in digital pathology helps enhance diagnostic accuracy, consistency, and speed by providing high-resolution images and advanced analysis tools.
"The VENTANA DP 600 high-capacity slide scanner creates high-resolution, digital images of stained tissue samples that help clinicians diagnose cancer and determine a patient's treatment," said Jill German, Head of Pathology Lab for听Roche Diagnostics. "The recent FDA clearances continue our momentum to advance the pathology lab's digital transformation and reinforce our commitment to enhance patient care and healthcare efficiency through streamlining the digital workflow."
The VENTANA DP 600 has 40 times the capacity of the VENTANA DP 200 and uses the same scanning technology, providing pathologists with consistent, high quality images from both systems. Roche Digital Pathology Dx now includes the VENTANA DP 200 slide scanner, the VENTANA DP 600 slide scanner, Roche's digital pathology workflow software and a display.
Roche Digital Pathology Dx is intended to aid the pathologist in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue when diagnosing patients.
About Roche Digital Pathology听
As the leading provider of pathology lab solutions, Roche is delivering an end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated AI-based image analysis algorithms. We minimise variables that can impact analysis, and it is this end-to-end development that produces the quality results healthcare providers and researchers can depend on. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice and is committed to investing in and shaping the future of pathology.
About Roche听
Founded in 1896 in
For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in
For more information, please visit .
All trademarks used or mentioned in this release are protected by law.
Roche Media Relations
Jo Lynn Garing, +1 317-363-7286 or jo_lynn.garing@roche.com
Amberly Peterson, +1 317-478-2210 or amberly.peterson@roche.com
View original content to download multimedia:
SOURCE Roche
FAQ
What is the scanning capacity of Roche's (RHHBY) new VENTANA DP 600 scanner?
When did Roche (RHHBY) receive the initial FDA clearance for Digital Pathology Dx system?
What components are included in Roche's (RHHBY) Digital Pathology Dx system?
What are the main benefits of Roche's (RHHBY) Digital Pathology Dx system for diagnosis?
What type of tissue samples can Roche's (RHHBY) Digital Pathology Dx system analyze?
