FDA clears Surgical Theater’s SyncAR Spine platform to enhance precision in spine surgery

Surgical Theater’s next-generation SyncAR Spine platform has received FDA 510(k) clearance, marking a significant advance in extended reality (XR) surgical tools powered by AI. The system integrates CT and MRI scans directly into the surgical field, allowing seamless transition from preoperative planning to intraoperative execution and providing surgeons with enhanced visibility and precision.

SyncAR Spine converts standard imaging into an interactive guide and works with the Medtronic StealthStation navigation system. Key features include AI-assisted vertebra segmentation, pre-surgical mapping for decompression, segmental fusion planning, and voxel-level drill tracking to monitor bone removal in real time. The platform also allows intraoperative access to MRI data, offering detailed views of vessels, nerves, and pathology to support minimally invasive procedures.

Unlike headset-dependent or standalone systems, SyncAR Spine is designed to integrate smoothly into existing surgical workflows, giving surgeons unprecedented insight, alignment between plan and execution, and real-time MRI guidance in the operating room.

13-10-2025