FDA OKs Surgical Theater’s Next-Gen, AI-Driven SyncAR Spine

Surgical Theater, a developer of surgical XR visualization, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for SyncAR Spine, the next generation of its spine platform.

The FDA nod expands the system’s capabilities with advanced XR tools that are powered by artificial intelligence (AI) algorithms. This brings MRI and CT into the operating room to align pre-op plans with intra-op execution for more clarity and control in spine surgery, according to the company.

SyncAR Spine converts traditional imaging into a dynamic surgical roadmap that’s integrated with Medtronic’s StealthStation navigation. The platform leverages AI-driven vertebra segmentation to streamline planning, Advanced Decompression Planning (ADP) to pre-map resections before surgery, and Segmental Fusion to keep pre-op models aligned with intra-op CT scans even as positioning changes.

Surgeons can track removal of bone in real-time with voxel-level drill tracking. They can also bring MRI data—including nerves, vessels, and pathology—into the OR.

Dr. Greg Poulter, a spine surgeon at OrthoIndy and the first to perform a SyncAR Spine case with the newly cleared next-generation platform said the technology gives him the visibility of open surgery in a minimally invasive case.

“Having MRI data live in the OR, aligned seamlessly with navigation, is the greatest improvement in navigation since its inception nearly two decades ago,” Dr Poulter told the press. “I can plan every detail in advance and then see that plan projected in real time during surgery, fully aligned with my workflow. That level of clarity changes how we operate.”

This latest FDA clearance was validated through comprehensive testing and AI-model performance studies. The company plans to premiere the updated platform at this year’s Congress of Neurological Surgeons (CNS) and North American Spine Society (NASS) meetings.

SyncAR was engineered as a comprehensive surgical XR platform, unlike those that rely on headset-only overlays or proprietary navigation. Surgical Theater’s XR platforms boast over 50,000 clinical uses within its XR platforms.

“SyncAR Spine represents the next step in that journey, bringing surgeons deeper insight, stronger alignment between plan and execution, and the unprecedented ability to carry MRI into the OR in real time,” said Surgical Theater president Alon Zuckerman. “This is a transformational leap in spine surgery.”