FDA OKs ZEISS’ Intrabeam 700 Robotic-Assisted Radiotherapy

ZEISS Medical Technology has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Intrabeam 700, a platform that provides robotic assistance to support intraoperative radiation therapy (IORT). Intrabeam 700 touts a digital-first architecture that aims to add value for neurooncology and breast cancer therapy.

The Intrabeam Smart Stand helps precisely precision the radiation applicator by allowing it to approach the cavity quickly and slow down when navigating within the cavity. Once the applicator’s in place, active damping and the stand dynamics minimize residual vibrations.

Smart Spherical Applicators feature digital-assisted applicator management and the related Spherical Sizer Set removes the need for sterilization. Draping and balancing functions help further support workflow efficiency—with one tap, all functions can be controlled with a graphical user interface (GUI).

Intrabeam’s redesigned Radiance treatment planning simulation software helps oncologists assess and simulate relevant intraoperative radiation dosage parameters based on patient data before treatment. It can be integrated into surgical infrastructure and the hospital information system, and application recognition and confirmation is integrated through embedded radiofrequency identification (RFID) technology.

Intrabeam is currently being used in multiple large clinical studies to research intra-op radiotherapy in brain tumors, with published clinical data. The company said work on new clinical and patient data in breast cancer is ongoing.

“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,” said 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 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 January, ZEISS earned an FDA nod for its MEL 90 excimer laser for the indications of myopia, hyperopia, and mixed astigmatism.