ZEISS receives FDA clearance for INTRABEAM 700

Jena, Germany | April 9, 2025 | Carl Zeiss Meditec AG

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."

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.

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.

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.

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.

^{*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.}