Cleveland, OH. - Surgical Theater, a surgical XR visualization company, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance for SyncAR Spine, the next-generation release of its spine platform. This clearance expands the system's capabilities with advanced XR tools powered by AI algorithms. This brings patient MRI and CT directly into the operating room, aligning preoperative plans with intraoperative execution for greater clarity and control in spine surgery.
SyncAR Spine transforms traditional imaging into a dynamic surgical roadmap, fully integrated with Medtronic StealthStation navigation. The platform incorporates AI-driven vertebra segmentation to streamline planning, Advanced Decompression Planning (ADP) to pre-map resections before surgery, and Segmental Fusion to keep preoperative models aligned with intraoperative CT scans even as patient positioning changes. Surgeons can track bone removal in real time with voxel-level drill tracking and, for the first time, bring MRI data, including nerves, vessels, and pathology into the OR, giving minimally invasive procedures the clarity once limited to open surgeries.
Dr. Greg Poulter, a spine surgeon at OrthoIndy and the first to perform a SyncAR Spine case with the newly cleared next-generation platform, emphasized its impact, saying, "SyncAR Spine gives me 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 2 decades ago. 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 marks SyncAR Spine as a major evolution of the platform, validated through comprehensive testing and AI-model performance studies. It reinforces Surgical Theater's leadership in surgical XR, setting a new standard for intraoperative visualization and delivering unmatched clinical utility for spine surgery.
Unlike platforms that rely on headset-only overlays or proprietary navigation, SyncAR Spine was designed as a comprehensive surgical XR platform. It integrates seamlessly with existing workflows, enhancing navigation rather than replacing it, and provides richer intraoperative visualization without disrupting surgical routines.
