Pixee Medical Announces CE Mark for Knee+ NexSight and Performs Europe’s First Augmented Reality Knee Surgeries

This next-generation AR guidance delivers robot-level precision without a robot, without pre-operative imaging and without disposables, tailored for high-volume operating rooms and Ambulatory Surgery Centers.

BESANÇON, France--(BUSINESS WIRE)--Pixee Medical, a pioneer in Augmented Reality (AR) guidance for orthopedic surgery, today announced it has received CE mark for Knee+ NexSight, its new AR-based solution for total knee arthroplasty, with the first procedures already performed in Europe.

Knee+ NexSight is already generating strong momentum in the field, with more than 20 procedures performed across France and Belgium by six surgeons, highlighting rapid adoption and clear clinical interest. The CE mark represents a major milestone toward global commercialization, with a 510(k) submission currently under review by the U.S. Food and Drug Administration (FDA).

Designed to meet the evolving demands of surgeons and the realities of high-throughput operating rooms, Knee+ NexSight projects a virtual screen directly into the surgeon’s field of view and incorporates voice command to enhance user experience. Lighter and more compact than the previous generation, the system requires no robot, no dedicated console, and no single-use disposables, helping to reduce capital investment, lower operating costs, and minimize environmental impact.

Knee+ NexSight is engineered to deliver robotic-level accuracy[1] while preserving efficiency, cost-effectiveness, and simplicity. The instrumentation is less invasive, can reduce blood loss[2], and integrates seamlessly into existing surgical workflows without adding operative time compared to conventional technique[2].

“This new version provides clear gains in speed, precision, and comfort during the procedure. It fits naturally into my surgical workflow and gives me strong confidence when planning and performing my bone cuts”, said Dr. Vidal, orthopedic surgeon and early user of previous Knee+ versions at Langres Hospital (France).

Knee+ NexSight is fully compatible with most primary knee implants and supports personalized alignment strategies, including kinematic alignment. Its software architecture is also designed for connectivity, enabling secure integration with third-party digital solutions and remote software updates as operating rooms become increasingly data-driven.

“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.

About Pixee Medical

Pixee Medical develops augmented reality solutions for implant placement, providing orthopedic surgeons with cutting-edge, clinically proven tools for precise and efficient surgery. Its first generation of products has already been used in over 10,000 procedures across more than 20 countries, demonstrating its positive impact on surgical practice worldwide. For more information, visit www.pixee-medical.com.

_[1] Lambrechts J, Vansintjan P, Lapierre C, Sinnaeve F, Van Lysebettens W, Van Overschelde. Accuracy of a New Augmented Reality Assisted Technique for Total Knee Arthroplasty: An In Vivo Study. Arthroplast Today. 2024.

_[2] Sameer Panchal, Benjamin Barker, Alan James Highcock.
Improved alignment and reduced peri-operative blood loss with augmented reality-guided total knee arthroplasty: a single-centre comparative study. 2026.