ZEISS receives FDA clearance for INTRABEAM 700

With its new treatment platform for intraoperative radiotherapy, ZEISS is actively shaping the medical innovation of neuro tumor therapy.

JENA, Germany, April 9, 2025 /PRNewswire/ -- As a leading provider of medical solutions in the field of neurosurgery, ZEISS Medical Technology is also dedicated to shaping modern oncology. The company recently received 510(k) clearance from the US Food and Drug Administration (FDA) for INTRABEAM^® 700 – a leading-edge platform that provides robotic-assisted precision to support intraoperative radiation therapy (IORT). With its modern digital-first architecture, ZEISS INTRABEAM 700 creates SMART workflow efficiency and provides seamless connectivity, offering real added value for neurooncology and breast cancer therapy.

"Based on our established INTRABEAM platform, the newly developed ZEISS INTRABEAM 700 marks the next major step on our path to shaping the oncology workflows of tomorrow," says Dr. Christian Schwedes, Head of the Neuro- and Spine Surgery Business Sector at ZEISS Medical Technology. "It is especially designed for a precise, structured and risk-adapted treatment of brain tumors. From smart robotic positioning of the system, a more efficient workflow before and during the application, to bringing the system into the 21^st century when it comes to digitalization and connectivity, the ZEISS INTRABEAM 700 will support the efficient and seamless collaboration between neurosurgery and oncological therapy."

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, West Virginia University, USA.

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 Boston, booth no. 625.

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

www.zeiss.com/newsroom          

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 €2,066.1m in fiscal year 2023/24 (to 30 September).

The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 39 percent of Carl Zeiss Meditec AG's shares are in free float. Approx. 59 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries.

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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SOURCE Carl Zeiss Meditec AG