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Next-generation AI-powered SyncAR® Spine receives FDA clearance for spine surgery – Ortho Spine News

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October 10, 2025
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Next-generation AI-powered SyncAR® Spine receives FDA clearance for spine surgery – Ortho Spine News

Dr. Poulter uses next-generation SyncAR Spine for minimally invasive TLIF

By bringing MRI and CT scans directly to the operating room, SyncAR Spine converts preoperative planning images into real-time intraoperative guidance.

CLEVELAND, Oct. 10, 2025 /PRNewswire/ — Surgical Theater, a leader in XR surgical visualization, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for SyncAR® Spine, the next-generation version of its spine platform. This authorization expands the system’s capabilities with advanced XR tools powered by AI algorithms. This brings the patient’s MRI and CT scan directly to the operating room, aligning preoperative plans with intraoperative execution for greater clarity and control in spine surgery.

Leveraging its proven foundation in operating rooms across the country, SyncAR Spine transforms traditional imaging into a dynamic surgical roadmap, fully integrated with Medtronic StealthStation™ navigation. The platform incorporates AI-powered vertebrae 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 position changes. Surgeons can track bone harvesting in real time with voxel-level drilling tracking and, for the first time, bring MRI data, including nerves, vessels and pathology, to the operating room, giving minimally invasive procedures the clarity previously limited to open surgeries.

Dr. Greg Poulter, world-renowned spine surgeon at OrthoIndy and the first to perform a SyncAR Spine case with the newly approved next-generation platform, emphasized its impact: “SyncAR Spine gives me the visibility of open surgery in a minimally invasive case. Having live MRI data in the OR, perfectly aligned with the navigation, is the biggest improvement in navigation since its inception almost 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 the way we operate.”

Next-generation AI-powered SyncAR® Spine receives FDA clearance for spine surgery – Ortho Spine News
Dr. Greg Poulter, OrthoIndy Spine Surgeon

This latest FDA clearance marks SyncAR Spine as a significant platform evolution, validated through extensive testing and AI model performance studies. It reinforces Surgical Theater’s leadership in surgical XR, setting a new standard for intraoperative visualization and providing unmatched clinical utility for spine surgery.

Surgical Theater will introduce this updated platform at two major upcoming events: the Congress of Neurological Surgeons (CNS) annual meeting and the North American Spine Society (NASS) annual meeting, where global spine leaders will have the opportunity to experience its new capabilities firsthand.

Unlike platforms that rely on dedicated headset overlays or proprietary navigation, SyncAR Spine was designed as a comprehensive XR surgical platform. It integrates seamlessly with existing workflows, enhancing rather than replacing navigation, and provides richer intraoperative visualization without disrupting surgical routines.

With over 50,000 clinical uses within its XR platforms, Surgical Theater continues to set the standard in surgical visualization. Alon Zuckerman, president of Surgical Theatre, said: “SyncAR Spine represents the next step in that journey, giving surgeons deeper insight, stronger alignment between plan and execution, and the unprecedented ability to bring MRI to the operating room in real time. This is a transformative leap in spine surgery.”

Alon Zuckerman, President, Operating Room

About the operating room

Surgical Theater is the leading and most widely used surgical XR visualization company. Its FDA-cleared eXperiential Reality® (XR) platform leverages artificial intelligence to transform traditional 2D scans into interactive 3D models that support clinical decisions across the entire continuum of care, from the clinic to the operating room. Surgeons use XR to walk through the anatomy, rehearse their plan, and align each intraoperative step with their preoperative strategy.

For media inquiries please contact:
tina badat
Vice President of Marketing
Surgical Theater
714.235.7980
tbadat@surgicaltheater.com

SOURCE Surgical Theater

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