Brainlab has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance and U.S. launch for its Spine Mixed Reality Navigation.

This surgical navigation tool gives users mixed reality support, providing an ergonomic view of the navigation screen. It also lets surgeons place pedicle screws with the vital information directly in their field of view.

The solution merges the company’s signature optical navigation system with advanced mixed reality. Extended visualization is projected in the sterile field, with real-time visualization of entry and target points—enabling desired pedicle screw placement according to the surgeon’s pre- or intraoperative plans. This includes minimally invasive surgical (MIS) cases where identifying the target is challenging.

Jason Pittman, MD, Ph.D., FAAOS, spine surgeon at Beth Israel Deaconess Medical Center in Boston and longtime Brainlab navigation user, provided crucial clinical feedback throughout Spine Mixed Reality Navigation’s development.

“Since my first introduction to Spine Mixed Reality Navigation at the Brainlab Usability Summit cadaver lab, I’ve been eager to work closely with them on their solution,” Dr. Pittman told the press. “Further hands-on opportunities at the company’s headquarters in Munich and Chicago have led me to believe that this solution is the future of the operating room. There is clear clinical value in Spine Mixed Reality Navigation with the enhanced visualization, accuracy and trueness.”

Dr. Pittman also said during the Usability Summit, the 3D “floating view” and virtual navigation views removed the need to continually look up from the operative site to the navigation screen and back. Users were able to efficiently place 100 screws over two days of testing.

“We’re ushering in the future of spine surgery, putting groundbreaking tools in the hands of U.S. surgeons,” said Sean Clark, president of Brainlab. “European surgeons are already experiencing the power to see, critically observe and optimize clinical procedures with Spine Mixed Reality Navigation. This solution delivers hyper realistic 3D visuals and extended visualization, while the workflow, instruments and navigation provide familiar and expected precision. Together with our customers, we’re driving accuracy in the OR.”