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 capacità del suo sistema di Diagnosi in Patologia Digitale. Questo scanner ad alta capacità può elaborare 240 vetrini e produce immagini digitali ad alta risoluzione di campioni tissutali colorati, rappresentando un significativo aggiornamento con una capacità 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 velocità diagnostica attraverso strumenti avanzati di analisi.
Roche (RHHBY) ha recibido una nueva autorización FDA 510(k) para su escáner VENTANA DP 600, ampliando las capacidades de su sistema de Diagnóstico en Patología Digital. Este escáner de alta capacidad puede procesar 240 portaobjetos y produce imágenes digitales de alta resolución de muestras de tejido teñidas, lo que representa una mejora significativa con 40 veces la capacidad del modelo previamente autorizado VENTANA DP 200.
El sistema, que recibió su autorización inicial de la FDA el 14 de junio de 2024, ayuda a los patólogos a revisar e interpretar imágenes digitales de tejidos fijados en formalina e incrustados en parafina (FFPE) para el diagnóstico de pacientes. El sistema completo de Diagnóstico en Patología Digital de Roche ahora incluye tanto los escáneres DP 200 como DP 600, software de flujo de trabajo y una pantalla, mejorando la precisión diagnóstica, la consistencia y la velocidad a través de herramientas avanzadas de análisis.
로슈(RHHBY)는 VENTANA DP 600 슬라이드 스캐너에 대한 추가 FDA 510(k) 승인을 받아 디지털 병리 진단 시스템의 기능을 확장했습니다. 이 고용량 스캐너는 240개의 슬라이드를 처리할 수 있으며, 염색된 조직 샘플의 고해상도 디지털 이미지를 생성합니다. 이는 이전에 승인된 VENTANA DP 200 모델의 용량인 40배의 성능 향상을 의미합니다.
이 시스템은 2024년 6월 14일에 최초 FDA 승인을 받았으며, 병리학자들이 포르말린에 고정된 파라핀 포함 조직(FFPE)의 디지털 이미지를 검토하고 해석하는 데 도움을 줍니다. 로슈의 디지털 병리 진단 시스템은 이제 DP 200과 DP 600 스캐너, 워크플로 소프트웨어 및 디스플레이를 포함하여, 고급 분석 도구를 통해 진단의 정확성, 일관성 및 속도를 향상시킵니다.
Roche (RHHBY) a reçu une autorisation supplémentaire FDA 510(k) pour son scanner VENTANA DP 600, élargissant ainsi les capacités de son système de diagnostic en pathologie numérique. Cet scanner à haute capacité peut traiter 240 lames et produit des images numériques haute résolution d'échantillons de tissus colorés, représentant une amélioration significative avec une capacité 40 fois plus grande que le modèle VENTANA DP 200 précédemment autorisé.
Le système, qui a reçu son approbation initiale de la FDA le 14 juin 2024, aide les pathologistes à examiner et interpréter des images numériques de tissus fixés au formol et inclus dans de la paraffine (FFPE) pour le diagnostic des patients. Le système complet de diagnostic en pathologie numérique de Roche comprend désormais les scanners DP 200 et DP 600, des logiciels de flux de travail et un écran, améliorant la précision, la cohérence et la rapidité des diagnostics grâce à des outils d'analyse avancés.
Roche (RHHBY) hat eine zusätzliche FDA 510(k) Genehmigung für seinen VENTANA DP 600 Folien-Scanner erhalten und erweitert damit die Funktionen seines digitalen Pathologie-Diagnosesystems. Dieser Hochleistungsscanner kann 240 Folien verarbeiten und erzeugt hochauflösende digitale Bilder von gefärbten Gewebeproben, was ein bedeutendes Upgrade mit einer 40-fachen Kapazität im Vergleich zum zuvor genehmigten Modell VENTANA DP 200 darstellt.
Das System, das am 14. Juni 2024 die ursprüngliche FDA-Zulassung erhielt, unterstützt Pathologen bei der Überprüfung und Interpretation digitaler Bilder von formalinfixierten, paraffineingebetteten (FFPE) Geweben zur Diagnostik von Patienten. Das vollständige 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 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
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
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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
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