Brainlab has received FDA 510(k) clearance and launched its Spine Mixed Reality Navigation system in the United States.

The new tool integrates mixed reality technology with the company’s existing optical navigation platform to assist with pedicle screw placement during minimally invasive spine surgeries.

The Munich-based company said the system enables surgeons to view navigation data overlaid within the surgical field via a mixed reality headset. By projecting real-time visualizations of entry and target points directly into the operative view, the system is intended to support accurate screw placement aligned with the surgical plan, especially in procedures where anatomical landmarks are less visible.
According to Brainlab, the platform is designed to reduce the need for surgeons to shift attention between the navigation screen and the patient, potentially streamlining workflow and minimizing cognitive load. The system supports both preoperative and intraoperative planning.

Dr. Jason Pittman, a spine surgeon at Beth Israel Deaconess Medical Center in Boston, contributed feedback during development. “There is clear clinical value in Spine Mixed Reality Navigation with the enhanced visualization, accuracy and trueness,” he said. He also noted the benefit of keeping surgical and navigational views aligned, citing improved ergonomics and workflow efficiency during cadaver lab testing.

Sean Clark, president of Brainlab Inc., said the system has already seen use in Europe. “This solution delivers hyper realistic 3D visuals and extended visualization, while the workflow, instruments and navigation provide familiar and expected precision,” he said.

Spine Mixed Reality Navigation is now available in the U.S. as part of Brainlab’s growing portfolio of digital surgery tools.

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