Surgical Theater Secures FDA Clearance for AI-Enhanced SyncAR Spine Surgical Visualization Platform

Cleveland-based Surgical Theater has announced U.S. FDA 510(k) clearance for its next-generation SyncAR Spine platform, expanding its use of artificial intelligence and extended reality (XR) to enhance precision in spine surgery. The updated platform enables surgeons to bring preoperative MRI and CT imaging directly into the operating room, transforming static scans into real-time intraoperative guidance.

SyncAR Spine is fully integrated with Medtronic’s StealthStation navigation system, allowing seamless alignment between preoperative plans and live surgical execution. The system now includes AI-powered vertebra segmentation to automate anatomical mapping, Advanced Decompression Planning (ADP) to pre-map bone resections, and Segmental Fusion technology that keeps models synchronized with intraoperative CT scans as patient positioning changes. These capabilities allow surgeons to visualize structures such as nerves, vessels, and pathology during minimally invasive procedures with the same clarity typically reserved for open surgeries.

Dr. Greg Poulter of OrthoIndy, who performed the first surgery using the newly cleared platform, described SyncAR Spine as “the greatest improvement in navigation since its inception nearly two decades ago.” He noted that the ability to view MRI data aligned with navigation in real time provides surgeons with a more detailed and efficient workflow, improving visualization and surgical outcomes.

The FDA clearance represents a major milestone for Surgical Theater, which has conducted extensive validation of the platform’s AI models and clinical performance. The company will showcase SyncAR Spine at the upcoming Congress of Neurological Surgeons (CNS) Annual Meeting and the North American Spine Society (NASS) Annual Meeting, offering surgeons the opportunity to experience its enhanced visualization tools firsthand.

Unlike traditional overlay-based XR systems, SyncAR Spine integrates directly into existing surgical workflows without requiring additional hardware or disrupting procedures. With more than 50,000 clinical uses of its XR technologies worldwide, Surgical Theater continues to advance intraoperative visualization. According to company president Alon Zuckerman, the new platform “brings deeper insight, greater precision, and the unprecedented ability to merge MRI data with live navigation — a transformative step forward in spine surgery.”