FDA grants 510(k) clearance to Surgical Theater’s spine platform
October 13, 2025
OrthoIndy spine surgeon Dr Greg Poulter performed the inaugural SyncAR Spine case.
OrthoIndy spine surgeon Dr Greg Poulter performed the inaugural SyncAR Spine case.
CLEVELAND, Oct. 10, 2025 /PRNewswire/ — Surgical Theater, the leader in surgical XR visualization, today 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.
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