Pixee Medical Wins EU Nod for Augmented Reality Knee Surgery Tech

Pixee Medical has earned CE mark approval for Knee+ NexSight, its new augmented reality (AR)-based solution for total knee arthroplasty. The first procedures were already performed in Europe.

Knee+ NexSight already has over 20 procedures performed across France and Belgium by six surgeons. The CE mark is a major milestone toward global commercialization, with a 510(k) submission currently under review by the U.S. Food and Drug Administration (FDA).

The technology projects a virtual screen directly into the surgeon’s field of view and incorporates voice command. Knee+ NexSight is lighter and more compact that the previous generation and the system needs no robot, dedicated console, or single-use disposables.

The system was engineered to provide robotic-level accuracy while preserving efficiency, cost-effectiveness, and simplicity. The company said the instrumentation is less invasive, can reduce blood loss, and integrates into existing surgical workflows without adding operative time compared to conventional technique.

Knee+ NexSight is compatible with most primary knee implants and supports personalized alignment, including kinematic alignment. Its software is designed for connectivity, allowing integration with third-party digital solutions and remote software updates.

“Knee+ NexSight is not just an incremental update; it is a new way to think about AR guidance in high-volume environments,” said Sébastien Henry, CEO of Pixee Medical. “It brings the accuracy of a robot in the form factor of a pair of glasses—without heavy infrastructure, without pre-operative imaging, and without disposables. We now look forward to FDA clearance so we can support the first procedures in the United States and expand access to this technology”, said Sébastien Henry, CEO of Pixee Medical.