ZEISS receives FDA clearance for INTRABEAM 700
ZEISS Medical Technology has received FDA 510(k) clearance for its INTRABEAM 700, an advanced platform for intraoperative radiation therapy (IORT). The system features robotic-assisted precision through the INTRABEAM SMART Stand, offering enhanced maneuverability and positioning control for neurooncology and breast cancer therapy.
The platform introduces SMART workflow efficiency with digital-first architecture, including sterile SMART Spherical Applicators, digital-assisted applicator management, and the redesigned Radiance™ treatment planning simulation software. The system enables seamless integration into hospital information systems and provides integrated applicator recognition through RFID technology.
ZEISS INTRABEAM is currently involved in multiple clinical studies, including phase 2 and 3 trials for brain metastases, glioblastoma, and breast cancer, with publications expected between 2025-2027.
ZEISS Medical Technology ha ricevuto l'approvazione 510(k) della FDA per il suo INTRABEAM 700, una piattaforma avanzata per la terapia radioterapica intraoperatoria (IORT). Il sistema presenta una precisione assistita da robot grazie all'INTRABEAM SMART Stand, offrendo una maggiore manovrabilità e controllo della posizione per la neuro-oncologia e la terapia del cancro al seno.
La piattaforma introduce l'efficienza del SMART workflow con un'architettura digitale-first, inclusi gli applicatori sferici SMART sterili, la gestione degli applicatori assistita digitalmente e il software di simulazione per la pianificazione del trattamento Radiance™ riprogettato. Il sistema consente un'integrazione senza soluzione di continuità nei sistemi informativi ospedalieri e fornisce un riconoscimento integrato degli applicatori tramite tecnologia RFID.
ZEISS INTRABEAM è attualmente coinvolto in diversi studi clinici, inclusi studi di fase 2 e 3 per metastasi cerebrali, glioblastoma e cancro al seno, con pubblicazioni attese tra il 2025 e il 2027.
ZEISS Medical Technology ha recibido la aprobación 510(k) de la FDA para su INTRABEAM 700, una plataforma avanzada para la terapia de radiación intraoperatoria (IORT). El sistema presenta precisión asistida por robots a través del INTRABEAM SMART Stand, ofreciendo mayor maniobrabilidad y control de posición para la neurooncología y la terapia del cáncer de mama.
La plataforma introduce la eficiencia del flujo de trabajo SMART con una arquitectura digital-first, incluyendo aplicadores esféricos SMART estériles, gestión de aplicadores asistida digitalmente y el software de simulación para la planificación del tratamiento Radiance™ rediseñado. El sistema permite una integración fluida en los sistemas de información hospitalaria y proporciona reconocimiento integrado de aplicadores a través de tecnología RFID.
ZEISS INTRABEAM está actualmente involucrado en múltiples estudios clínicos, incluidos ensayos de fase 2 y 3 para metástasis cerebrales, glioblastoma y cáncer de mama, con publicaciones esperadas entre 2025 y 2027.
ZEISS Medical Technology는 INTRABEAM 700에 대해 FDA 510(k) 승인을 받았습니다. 이는 수술 중 방사선 치료(IORT)를 위한 고급 플랫폼입니다. 이 시스템은 INTRABEAM SMART Stand를 통해 로봇 보조 정밀성을 제공하며, 신경종양학 및 유방암 치료를 위한 향상된 조작성과 위치 제어를 제공합니다.
이 플랫폼은 멸균된 SMART 구형 적용기, 디지털 지원 적용기 관리 및 재설계된 Radiance™ 치료 계획 시뮬레이션 소프트웨어를 포함한 디지털 우선 아키텍처로 SMART 작업 흐름 효율성을 도입합니다. 이 시스템은 병원 정보 시스템과의 원활한 통합을 가능하게 하며 RFID 기술을 통해 통합된 적용기 인식을 제공합니다.
ZEISS INTRABEAM은 현재 뇌 전이, 교모세포종 및 유방암에 대한 2상 및 3상 시험을 포함한 여러 임상 연구에 참여하고 있으며, 2025년부터 2027년 사이에 발표될 예정입니다.
ZEISS Medical Technology a reçu l'approbation 510(k) de la FDA pour son INTRABEAM 700, une plateforme avancée pour la thérapie de radiothérapie intra-opératoire (IORT). Le système présente une précision assistée par robot grâce au INTRABEAM SMART Stand, offrant une meilleure maniabilité et un contrôle de position pour la neuro-oncologie et la thérapie du cancer du sein.
La plateforme introduit l'efficacité du flux de travail SMART avec une architecture numérique-first, y compris des applicateurs sphériques SMART stériles, une gestion des applicateurs assistée numériquement et le logiciel de simulation de planification de traitement Radiance™ repensé. Le système permet une intégration fluide dans les systèmes d'information hospitaliers et fournit une reconnaissance intégrée des applicateurs grâce à la technologie RFID.
ZEISS INTRABEAM est actuellement impliqué dans plusieurs études cliniques, y compris des essais de phase 2 et 3 pour les métastases cérébrales, le glioblastome et le cancer du sein, avec des publications attendues entre 2025 et 2027.
ZEISS Medical Technology hat die FDA 510(k)-Zulassung für ihr INTRABEAM 700 erhalten, eine fortschrittliche Plattform für die intraoperative Strahlentherapie (IORT). Das System bietet robotergestützte Präzision durch den INTRABEAM SMART Stand und ermöglicht eine verbesserte Manövrierfähigkeit und Positionskontrolle für die Neuroonkologie und die Brustkrebstherapie.
Die Plattform führt die SMART Workflow-Effizienz mit einer digitalen Architektur ein, die sterile SMART Spherical Applicators, digital unterstützte Anwendungsverwaltung und die neu gestaltete Radiance™-Software zur Behandlungsplanung umfasst. Das System ermöglicht eine nahtlose Integration in Krankenhausinformationssysteme und bietet integrierte Anwendungskennung durch RFID-Technologie.
ZEISS INTRABEAM ist derzeit an mehreren klinischen Studien beteiligt, darunter Phase-2- und Phase-3-Studien zu Hirnmetastasen, Glioblastom und Brustkrebs, mit Veröffentlichungen, die zwischen 2025 und 2027 erwartet werden.
- FDA 510(k) clearance received for new INTRABEAM 700 platform
- Advanced robotic-assisted precision technology for improved treatment accuracy
- Digital integration capabilities with hospital information systems
- Multiple ongoing clinical trials in brain cancer and breast cancer treatments
- Clinical trial results pending with publications not expected until 2025-2027
- Effectiveness data from ongoing studies not yet available
With its new treatment platform for intraoperative radiotherapy, ZEISS is actively shaping the medical innovation of neuro tumor therapy.
JENA,
"Based on our established INTRABEAM platform, the newly developed ZEISS INTRABEAM
Robotic-assisted Precision
In oncological treatments, it must be ensured that the target area is optimally resected, and that healthy tissue is spared as much as possible. Especially during contact irradiation, it is important that the target focus always remains the same throughout the entire treatment, without interruptions or unintended movements. The cutting-edge maneuverability of the brand-new robotic ZEISS INTRABEAM SMART Stand meets these clinical requirements and offers excellent positioning control at every stage of the treatment.
ZEISS INTRABEAM SMART Stand supports the precise positioning of the applicator by allowing it to approach the cavity fast, but also to slow down the speed of movement when navigating the applicator within the cavity. Once the applicator is in place, the active damping and the stand dynamics reduce residual vibrations to a minimum.
"The new incarnation of the INTRABEAM 700 really gives you more range of motion in the delivery of the applicator to the cavity. It gives you precision in how movements can be made inside of the resection cavity by the applicator," says Christopher Cifarelli, MD Neurosurgeon,
SMART Workflow Efficiency
To achieve the best patient outcomes, healthcare professionals would like to focus solely on the treatment. ZEISS INTRABEAM 700 offers Smart Workflow Efficiency based on a digital-first architecture:
The new sterile ZEISS INTRABEAM SMART Spherical Applicators come with digital-assisted applicator management and the related ZEISS INTRABEAM Spherical Sizer Set also eliminates the need for sterilization. The convenient and smart draping and balancing functions support clinical workflow efficiency further. With a single tap, all functions can be controlled with a modern and intuitive graphical user interface (GUI), familiar from other ZEISS devices.
Furthermore, the completely redesigned Radiance™ treatment planning simulation software enables oncologists to assess and simulate all relevant intraoperative radiation dosage parameters based on individual patient data prior to treatment in a simpler and faster workflow, reducing unexpected treatment disruptions during surgery. This is key to successful surgical oncology procedures, resulting in optimal patient outcomes.
Seamless Connectivity
As part of the digitalization megatrend, connectivity is also becoming increasingly important in surgical oncology workflows worldwide. ZEISS INTRABEAM 700 can be integrated seamlessly into the surgical infrastructure and the hospital information system. Direct access to leading digital solutions from ZEISS enables faster routine workflows and simplified data management. The platform also provides integrated applicator recognition and confirmation through embedded Radio Frequency Identification (RFID) technology.
For progress in medical technology
The latest generation of the INTRABEAM platform highlights ZEISS' innovative strength and is an example of how the company is driving medical innovation in cancer therapy: INTRABEAM from ZEISS is currently already used in multiple large clinical studies to research intraoperative radiotherapy in brain tumors, and clinical data has already been published. In addition, work on new clinical and patient-related data in the field of breast cancer is ongoing.*
ZEISS will present its latest solution for intraoperative radiotherapy from April 25 to 28, 2025, at the American Association of Neurological Surgeons Annual Scientific Meeting (AANS) in
* | INTRAMET – phase 2 study – Brain Metastases – publication expected in 2026; INTRAGO II – phase 3 study – Glioblastoma – completed in 2024 (publication expected for 2026); TARGIT-E – phase 3 study Breast cancer in elderly patients – publication expected in 2025; TARGIT-US – phase 4 study Breast cancer – publication expected in 2027. |
Contact for investors and the press
Sebastian Frericks
Head of Group Finance and Investor Relations
Carl Zeiss Meditec AG
Phone: +49 3641 220 116
Mail: investors.med@zeiss.com
Brief Profile
Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on the MDAX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With 5,730 employees worldwide, the Group generated revenue of
The Group's head office is located in Jena,
For further information visit: www.zeiss.com/med
Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country-specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development. The statements of the healthcare professionals reflect only their personal opinions and experiences and do not necessarily reflect the opinion of any institution that they are affiliated with. The healthcare professionals alone are responsible for the content of their experience reported and any potential resulting infringements. Carl Zeiss Meditec AG and its affiliates to not have clinical evidence supporting the opinions and statements of the health care professionals nor accept any responsibility or liability of the healthcare professionals' content. The healthcare professionals have a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and have received financial support.
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FAQ
What are the key features of ZEISS INTRABEAM 700's FDA-cleared radiation therapy system?
Which clinical trials are currently ongoing for ZEISS INTRABEAM technology?
How does the INTRABEAM SMART Stand improve treatment precision?
What workflow improvements does the Radiance™ treatment planning software provide?
