FDA Clears ZEISS INTRABEAM 700 for Intraoperative Radiation Therapy in Neuro-Oncology & Breast Cancer

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The FDA has granted 510(k) clearance to the ZEISS INTRABEAM 700 platform, enabling its use as a robotic-assisted system to support intraoperative radiation therapy in neuro-oncology and breast cancer surgery.1

The INTRABEAM 700 platform integrates digital-first design with robotic-assisted precision to optimize procedural efficiency and multidisciplinary connectivity. Once the applicator is in place in the surgical cavity, the ZEISS INTRABEAM SMART Stand employs active vibration damping and robotic stand dynamics to reduce residual motion and enhance intraoperative accuracy. The construction of the SMART Stand is intended to accelerate workflow efficiency.

“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,” Christopher Cifarelli, MD, PhD, MMM, FAANS, FACS, a neurosurgeon, professor, and director of the Gamma Knife Program, at West Virginia University in Morgantown, explained in a news release.

A key advancement in the INTRABEAM 700 platform is the introduction of sterile ZEISS INTRABEAM SMART Spherical Applicators, which feature digital-assisted applicator management. Additionally, the ZEISS INTRABEAM Spherical Sizer Set eliminates the need for sterilization. Smart draping and balancing functions further improve workflows, and a modern graphical user interface—consistent with those in other ZEISS devices—allows clinicians to control all system functions with a single tap.

Complementing the platform is the redesigned Radiance treatment planning simulation software. Radiance enables clinicians to preoperatively assess and simulate intraoperative radiation dose parameters using patient-specific data. This functionality supports a more predictable treatment process by reducing unexpected disruptions during surgery, which may ultimately improve outcomes.2

“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,” Christian Schwedes, PhD, head of the Neuro and Spine Surgery Business Sector at ZEISS Medical Technology, added in the news release.1 “It is especially designed for a precise, structured, and risk-adapted treatment of brain tumors. From smart robotic positioning of the system [and] a more efficient workflow before and during the application to bringing the system into the 21st 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 addition to platform enhancements and software integration, the ZEISS INTRABEAM 700 system introduces a new suite of RFID-equipped applicators designed to further streamline intraoperative radiation delivery and improve procedural precision.2

The ZEISS INTRABEAM SMART Spherical Applicators are engineered for intracavity or intraoperative radiation administration directly to the tumor bed. These sterile, single-use applicators are color-coded by size to facilitate quick identification and selection during procedures.

To assist with optimal applicator selection, the ZEISS INTRABEAM Spherical Sizer Set provides a sterile, single-use solution comprising 4 differently sized sizers. This set allows physicians to evaluate and determine the best-fitting applicator based on the dimensions of the tumor cavity. Color coding—consistent with that used on the SMART Spherical Applicators—further simplifies intraoperative decision-making.

Additionally, the ZEISS INTRABEAM Needle Applicator is available for the interstitial irradiation of tumors, with specific applications in managing vertebral metastases and select brain tumors. This applicator is also sterile and designed for single use.

ZEISS will present its latest solution for intraoperative radiotherapy at the American Association of Neurological Surgeons Annual Scientific Meeting, which will take place from April 25 to 28, 2025, in Boston, Massachusetts.1

References

1. ZEISS receives FDA-clearance for INTRABEAM 700. ZEISS. April 9, 2025. Accessed April 9, 2025. https://www.zeiss.com/meditec-ag/en/media-news/press-releases/2025/fda-clearance-intrabeam.html
2. ‌ ZEISS INTRABEAM 700. ZEISS. Accessed April 9, 2025. https://www.zeiss.com/meditec/en/products/intrabeam-700.html#