The US Food and Drug Administration (FDA) has granted 510(k) clearance to Surgical Theater’s next-generation platform, SyncAR Spine.
The decision enhances the platform’s suite of extended reality (XR) tools, which are underpinned by AI algorithms.
SyncAR Spine enables the direct incorporation of computed tomography scans and magnetic resonance imaging (MRI) into the surgical environment, facilitating a transition from preoperative planning to intraoperative execution.
This is expected to provide surgeons with visibility and precision during procedures.
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The platform is said to transform standard imaging into an interactive surgical guide, integrating with the Medtronic StealthStation navigation system.
It includes features such as AI-assisted vertebra segmentation for planning, pre-surgical mapping of resections through advanced decompression planning, and segmental fusion technology to maintain the alignment of preoperative models with intraoperative imaging, despite patient movement.
A key advancement with SyncAR Spine is the ability for surgeons to monitor the real-time removal of bone using voxel-level drill tracking.
Additionally, the system allows MRI data to be accessible during surgery, which includes detailed views of vessels, nerves, as well as pathology, thereby enhancing the visual clarity for minimally invasive procedures.
OrthoIndy spine surgeon Dr Greg Poulter performed the inaugural SyncAR Spine case with the new platform.
Poulter said: “SyncAR Spine gives me the visibility of open surgery in a minimally invasive case. Having MRI data live in the operating room (OR), aligned seamlessly with navigation, is the greatest improvement in navigation since its inception nearly two decades ago.”
SyncAR Spine is designed to be an all-encompassing surgical XR platform that integrates with current surgical workflows, unlike other systems that depend on headset overlays or stand-alone navigation, the company added.
Surgical Theater president Alon Zuckerman said: “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. This is a transformational leap in spine surgery.”
