FDA Clears ZEISS INTRABEAM 700 for IORT in Cancer Surgery
The FDA has granted 501(k) clearance to ZEISS INTRABEAM 700, a robotic-assisted platform designed to enhance intraoperative radiation therapy.
US FDA
- The FDA granted 510(k) clearance to ZEISS INTRABEAM 700 for enhanced intraoperative radiation therapy (IORT).
- ZEISS INTRABEAM 700 allows for robotic-assisted precision to provide support during the whole surgical oncology workflow.
- Digital tools and software like this streamline planning, data access, and surgical integration.1
The ZEISS INTRABEAM 700 has received FDA 510(k) clearance for enhanced IORT. This next-generation platform incorporates robotic precision, digital-first workflow, and integrated connectivity, making it useful for oncologic surgeons, particularly in neuro-oncology and breast cancer.1
The system works by delivering robotic-assisted precision throughout the surgical oncology workflow, enabling better control during intraoperative radiation therapy.2 Its advanced SMART Stand allows seamless transition between rapid approach and fine-tuned navigation modes, all of which are managed through touch controls.
The system also ensures precise applicator positioning. Once in place, active vibration damping and dynamic stabilization maintain optimal alignment and support consistent and effective radiation delivery.
"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, said in a press release.1 "It is especially designed for a precise, structured and risk-adapted treatment of brain tumors.”
Scientist analyzing microscope slide at laboratory. Young woman technician is examining a histological sample, a biopsy in the laboratory of cancer research: © Chockniti- stock.adobe.com
Efficiency is central to ZEISS INTRABEAM 700. The system uses single-use, sterile applicators and sizers to reduce preparation time and eliminate sterilization needs. Radio frequency identification (RFID)-assisted applicator management improves traceability and safety, and all functions can be controlled with a modern graphical user interface that simplifies control for surgical staff.1
The integrated Radiance™ software enables real-time radiation planning based on individual patient data. This supports preoperative assessment and intraoperative confidence, minimizes unplanned treatment interruptions, and supports optimal radiation dosing to better clinical outcomes.1
ZEISS INTRABEAM 700 also integrates smoothly into surgical infrastructure and hospital’s information systems. The platform also offers access to ZEISS digital solutions for improved data handling and clinical decision-making and provides automated applicator recognition via embedded RFID.1
“From smart robotic positioning of the system, 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," added Schwedes.
The INTRABEAM platform is already part of several major clinical trials, including:
- INTRAGO-II (NCT02685605): Phase 3 trial in glioblastoma that was completed 2024. Publication of the data is expected in 2026.
- INTRAMET (NCT03226483): Ongoing phase 2 trial for brain metastases. Results are expected in 2026.
- TARGIT-E (NCT01299987): Prospective phase 3 trial for the treatment of elderly patients with breast cancer. The publication is due in 2025.
- TARGIT-US (NCT01570998): Phase 4 trial in patients with breast cancer undergoing breast-conserving surgery. Results are expected in 2027.
"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," said Christopher Cifarelli, MD, neurosurgeon, West Virginia University, in the press release.1
