Besançon, France-based Pixee designed its augmented reality (AR)-based solution for total knee arthroplasty. It already reports more than 20 procedures performed across France and Belgium by six surgeons. With CE mark in hand, the company now awaits the FDA’s review of a 510(k) clearance submission in the U.S.
The company already brought its previous-generation Knee NexSight system to the U.S., announcing the first U.S. procedure in May 2025. It had just unveiled the technology at AAOS in March 2025.
“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.”
More about the latest technology from Pixee Medical
Pixee designed its Knee+ NexSight to meet the evolving needs of surgeons and the realities of high-throughput operating rooms. It projects a virtual screen directly onto the surgeon’s field of view and incorporates voice command to enhance user experience.
The new solution comes in lighter and more compact than the previous generation. It also requires no robot, no dedicated console and no single-use disposables. This aims to reduce capital investment, lower operating costs and minimize environmental impact.
Pixee says the platform delivers robotic-level accuracy while preserving. efficiency, cost-effectiveness and simplicity. It offers less invasive instrumentation to reduce blood loss while integrating seamlessly into existing surgical workflows, the company says.
Knee+ NexSight has full compatibility with most primary knee implants and supports personalized alignment strategies. That includes kinematic alignment. The platform’s software architecture also enables connectivity to deliver secure integration with third-party digital solutions. Remote software updates also come into play as operating rooms become increasingly data-driven, Pixee, said.
