ZEISS receives FDA clearance for INTRABEAM 700
Rhea-AI Summary
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.
Positive
- 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
Negative
- Clinical trial results pending with publications not expected until 2025-2027
- Effectiveness data from ongoing studies not yet available
News Market Reaction – CZMWY
In the trading session that priced this news, CZMWY gained 14.01%, reflecting a significant positive market reaction.
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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.
