Radiosurgery Planning System Receives FDA 510(k), CE Clearance

Nov. 11, 2025 — ZAP Surgical Systems recently announced its ZAP-Axon Radiosurgery Planning System has received both U.S. FDA 510(k) clearance and European CE certification. These key regulatory milestones authorize clinical use of ZAP-Axon throughout the United States and European Union, marking a significant advance in the evolution of world-class radiosurgery planning.

Dedicated exclusively to cranial stereotactic radiosurgery (SRS), ZAP-Axon eliminates the time-consuming and cumbersome interfaces of multi-purpose planning software originally developed for full-body applications and diverse radiation delivery techniques. Instead, Axon delivers a focused, intuitive environment where sophisticated data visualization meets seamless usability - empowering clinicians to plan radiosurgery cases with greater efficiency and clarity.

ZAP-Axon was developed in parallel with the company’s ZAP-X® Gyroscopic Radiosurgery platform, enabling seamless integration between planning and delivery for enhanced workflow efficiency and treatment precision.

“By eliminating unnecessary complexity and clutter, Axon’s streamlined interface allows clinicians to quickly master advanced radiosurgery planning - without the complicated navigation common in legacy systems,” said John R. Adler, MD, Professor Emeritus of Neurosurgery at Stanford University and Founder & CEO of ZAP Surgical Systems. “Axon gives clinicians a clean, focused environment where advanced radiosurgery planning becomes second nature.”

Central to Axon’s innovation is a Krylov quadratic optimizer that enhances treatment quality and helps to safeguard critical brain structures by enabling clinicians to rapidly generate and compare multiple candidate plans. What once took 20 minutes can now be achieved in just 30–45 seconds, allowing for far more thorough plan evaluation and refinement.

“As the first system in its field built entirely on modern web technologies, Axon is uniquely positioned to rapidly integrate and fully harness the power of AI,” noted Alex Maslowski, PhD, Vice President of Software at ZAP Surgical. “We’re witnessing the beginning of an entirely new generation in high-precision radiosurgery planning.”

When paired with the ZAP-X platform, Axon enables the full potential of the world’s first and only vault-free, cobalt-free radiosurgery system. ZAP-X utilizes an advanced gyroscopic architecture to deliver thousands of potential non-isocentric beam angles for superior dose conformity and healthy tissue preservation - all without the need for costly shielded treatment bunkers or radioactive sources.

For more information about ZAP Surgical and the ZAP-X system, visit www.zapsurgical.com.