#United States #Cleveland #FDA #Surgical Theater #SyncAR Spine

Transforming Spine Surgery with SyncAR® Spine

The future of spine surgery has just taken a significant leap forward with the recent approval of SyncAR® Spine by the U.S. Food and Drug Administration (FDA). Surgical Theater, a company known for its pioneering work in surgical XR (extended reality) visualization, announced that its next-generation platform has received 510(k) clearance, pushing the boundaries of how surgeries are planned and executed. This innovation is set to enhance the clarity and control of spinal procedures, merging advanced technology with traditional surgical practices.

Real-Time Imaging in the Operating Room

One of the standout features of SyncAR® Spine is its ability to seamlessly bring patient MRI and CT imaging into the operating room. This integration allows surgeons to use preoperative planning data as real-time guidance during surgery. Dr. Greg Poulter, a leading spine surgeon at OrthoIndy, was one of the first to utilize this platform in a minimally invasive procedure, emphasizing how the platform provides visibility comparable to that of open surgery. "Having MRI data live in the OR, aligned seamlessly with navigation, is the greatest improvement in navigation since its inception nearly two decades ago," he stated.

This technology is not merely about visualization; it transforms surgical workflows by enabling AI-driven tools that assist in vertebra segmentation and advanced decompression planning. It allows for meticulous pre-mapping of surgical resections, ensuring a streamlined approach from planning to execution.

Advantages over Conventional Methods

The SyncAR® Spine platform enhances traditional imaging by turning it into a dynamic surgical roadmap. Unlike other systems that rely solely on headset overlays or proprietary navigation solutions, SyncAR® Spine is designed as a comprehensive XR tool. It enriches intraoperative visualization without interrupting standard surgical routines. With this platform, tracking bone removal can occur in real-time, further improving the precision of the procedure.

Moreover, the system's ability to maintain alignment between preoperative models and intraoperative CT scans ensures that the surgical plan stays on track, regardless of any changes in patient positioning during the procedure. This advancement is groundbreaking for minimally invasive procedures, which have often struggled to maintain the level of clarity afforded to open surgeries.

A Major Step Forward

The FDA's recent clearance underscores the substantial testing and findings supporting the efficacy of SyncAR® Spine. With over 50,000 clinical uses of Surgical Theater's XR platforms, the company's commitment to advancing surgical visualization is evident. Alon Zuckerman, President of Surgical Theater, remarked on this development, stating, "SyncAR® Spine represents the next step in our journey, bringing surgeons deeper insight and stronger alignment between planning and execution. This is a transformational leap in spine surgery."

Surgical Theater will showcase its SyncAR® Spine platform at significant industry events like the Congress of Neurological Surgeons (CNS) Annual Meeting and the North American Spine Society (NASS) Annual Meeting. These gatherings will provide an opportunity for spine leaders from around the world to experience the next generation of surgical visualization firsthand.

In summary, the FDA's clearance of the SyncAR® Spine platform marks a pivotal moment in the evolution of surgical practices. By seamlessly integrating advanced imaging technologies into the operating room, it significantly enhances the precision and effectiveness of spine surgery, setting a new standard for future surgical interventions.