CHICAGO– Brainlab, a digital medical technology company, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and officially launched Spine Mixed Reality Navigation in the United States. The advanced surgical navigation platform combines the precision of Brainlab’s signature optical navigation system with mixed reality, giving surgeons enhanced visualization support during minimally invasive spine surgery.
The system projects real-time navigation information directly into the surgeon’s field of view, allowing precise pedicle screw placement in both open and minimally invasive procedures. By eliminating the need to repeatedly shift attention between the operative site and a separate navigation screen, Spine Mixed Reality Navigation improves ergonomics, reduces cognitive load, and enables greater surgical efficiency.
“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,” said Jason Pittman, M.D., Ph.D., FAAOS, a spine surgeon at Beth Israel Deaconess Medical Center in Boston and long-time Brainlab navigation user. “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 noted that the headset delivers vital navigation information alongside the patient’s anatomy, allowing surgeons to maintain constant focus on the operative site. He said the headset was comfortable even during long sessions and highlighted its potential to support collaboration with colleagues and residents inside and outside the sterile field.
“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, Inc. “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 O.R.”
The clearance and U.S. launch mark a milestone for Brainlab and for the advancement of spinal surgery, as the company continues to expand the role of mixed reality in operating rooms worldwide.
