ZAP Surgical Systems gains FDA, CE Clearance for AI-ready brain radiosurgery planning platform

ZAP Surgical Systems Inc. announced that its ZAP-Axon Radiosurgery Planning System has received U.S. FDA 510(k) clearance and European CE certification, paving the way for clinical use across both markets. The company described the dual approvals as a major step forward in advancing non-invasive brain surgery through streamlined, high-precision planning tools.

ZAP-Axon is purpose-built for cranial stereotactic radiosurgery (SRS), offering a focused alternative to multi-purpose radiation planning software originally designed for full-body use. Developed in tandem with the company’s ZAP-X Gyroscopic Radiosurgery system, Axon provides an integrated environment for planning and delivering treatment, with an emphasis on speed, accuracy, and usability.

“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.”

According to the company, a key feature of the software is its Krylov quadratic optimizer, which allows clinicians to generate and compare multiple treatment plans in less than a minute—tasks that traditionally took 20 minutes or more. The result is faster, more refined decision-making and greater protection for critical brain structures.

“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,” said Alex Maslowski, PhD, vice president of Software at ZAP Surgical.

When paired with ZAP’s gyroscopic delivery platform, Axon supports a fully vault-free, cobalt-free radiosurgery system designed to provide thousands of potential non-isocentric beam angles for highly conformal dose delivery without the need for shielded treatment bunkers.

Advances in radiosurgery technology

The field of stereotactic radiosurgery has seen rapid innovation in recent years, driven by the convergence of robotics, imaging, and artificial intelligence. These technologies are transforming how clinicians target and treat brain tumors and other neurological conditions with sub-millimeter accuracy—often in outpatient settings and without surgical incisions.

One of the most significant trends is the rise of automated treatment planning powered by AI algorithms that can rapidly optimize radiation dose distributions while sparing nearby healthy tissue. These tools allow clinicians to explore multiple treatment scenarios in a fraction of the time required by manual planning, potentially improving both precision and patient outcomes.

Advances in imaging have also enhanced the precision of radiosurgery. High-resolution MRI and functional imaging now provide detailed maps of brain structures and neural pathways, allowing physicians to better distinguish between tumor tissue and critical functional areas. Coupled with real-time motion tracking and adaptive planning, radiosurgery systems can dynamically adjust to subtle patient movements or changes in anatomy.

Meanwhile, hardware innovations have focused on improving beam delivery mechanisms—reducing treatment time and eliminating reliance on radioactive cobalt sources. Modern robotic systems can deliver radiation from thousands of angles, creating highly conformal dose patterns that minimize exposure to healthy tissue.

Together, these developments are redefining the role of radiosurgery in neurology and oncology. What was once reserved for inoperable brain tumors is increasingly being explored for conditions such as epilepsy, Parkinson’s disease, and vascular malformations. As software platforms become more intelligent and integrated, radiosurgery is poised to become faster, safer, and more widely accessible than ever before.