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Brainlab gets FDA clearance for Spine Mixed Reality Navigation system

The offering projects real-time 3D visuals of screw placement into a surgeon's field of view to improve accuracy in spine surgery.
By Jessica Hagen , Executive Editor
Surgeon using mixed reality

Photo courtesy of Brainlab

German surgical navigation software company Brainlab has received U.S. FDA 510(k) clearance for its Spine Mixed Reality Navigation system, which combines a surgical navigation system with mixed reality. 

The system allows surgeons to have an ergonomic view of the navigation screen and see the pedicle screws within their line of sight and within the same field of view as a patient's anatomy.  

The extended visualization is projected directly in the sterile field, providing real-time visuals of entry and target points. 

Brainlab says this allows for the desired placement of the screws per the surgeon's pre- or intraoperative plans, including during minimally invasive spine surgery. 

"European surgeons are already experiencing the power to see, critically observe and optimize clinical procedures with Spine Mixed Reality Navigation," said Sean Clark, president of Brainlab. 

"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 LARGER TREND

Earlier this year, Brainlab announced its plan to go public on the Frankfurt Stock Exchange, aiming to raise €200 million for growth in its initial public offering. 

However, listing plans were subsequently put on hold due to volatile stock markets, according to Reuters

"We have to recognise that the current geopolitical uncertainties continue to have a significant impact on the international capital markets," wrote Rainer Birkenbach, CEO of Brainlab, in an internal memo seen by Reuters. He said that at the time, an IPO did not offer optimal conditions for the company.

Another company offering a mixed reality surgical navigation system is Augmedics, providing an augmented reality surgical navigation platform for spine procedures. 

The company's xvision Spine System uses a transparent near-eye display headset to project a 3D visualization of a patient’s spine generated from pre-operative CT scans directly into a surgeon’s retina.