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Home » Pixee wins FDA nod for next-gen AR knee surgery tech

Pixee wins FDA nod for next-gen AR knee surgery tech

April 27, 2026 By Sean Whooley

Pixee Medical Knee+ NexSight
The Knee+ NexSight AR-powered surgical system in use. [Image courtesy of Pixee Medical]
Pixee Medical announced today that it received FDA 510(k) clearance for its Knee+ NexSight augmented reality (AR)-based solution.

Besançon, France-based Pixee designed its AR-based technology for total knee arthroplasty (TKA) procedures. 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.

Clearance allows Pixee to bring the latest AR technology to the U.S., following its CE mark and subsequent launch in Europe last month. The company said its focus centers on ambulatory surgery centers (ASCs), with the technology designed to integrate seamlessly into the high-demand environments, streamlining workflows without adding complexity.

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 capabilities to enhance user experience.

The new solution is 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, including kinematic alignment. The platform’s software architecture also enables connectivity to deliver secure integration with third-party digital solutions.

Sébastien Henry, CEO of Pixee Medical, said:

“We’ve always believed that precision in surgery shouldn’t come at the cost of usability. With this new AR platform, Knee+ NexSight brings robotic-level accuracy into a system surgeons actually want to use, more compact, fully hands-free, and built to fit the flow of the OR rather than reshape it around itself. FDA clearance now allows us to put that experience in the hands of U.S. surgeons.

Filed Under: 510(k), Artificial Intelligence (AI), Digital Health, Food & Drug Administration (FDA), Health Technology, Machine Learning (ML), Orthopedics, Regulatory/Compliance, Software / IT, Surgical Tagged With: FDA, Pixee Medical

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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