Pixee Medical, a pioneer in augmented reality (AR) navigation for orthopedic surgery, has earned U.S. Food and Drug Administration (FDA) 510(k) cleaqrance for Knee⁺ NexSight, its new AR guidance solution for total knee arthroplasty (TKA).

This next-gen AR tool was designed to address the burgeoning market of ambulatory surgical centers (ASCs).

Knee⁺ NexSight was developed in collaboration with orthopedic surgeons and built on a platform with over 10,000 successful procedures worldwide. Pixee said it can meet the unique demands of high-efficiency, cost-sensitive U.S. surgical environments.

Using it, surgeons have access to advanced wearable guidance that boosts intra-operative decisions and reproducibility without needing robotic systems or a significant capital investment. It’s compatible with all primary total knee implants and can integrate easily into diverse surgical settings, the company said.

The AR guidance tool features an optional connectivity module to allow secure data exchange with third-party web solutions. This way, data can be securely shared and software updates done seamlessly.

Dr. Scott Nodzo, an orthopedic surgeon in Buffalo, N.Y., said Knee⁺ NexSight lets surgeons position knee implants with remarkable precision, according to exact specifications determined for each patient.

“This augmented reality technology eliminates the need for costly preoperative imaging while ensuring placement precision to the degree,” Dr. Nodzo told the press. Compatible with all existing implant systems, Knee⁺ NexSight integrates naturally into surgeons’ usual procedures, minimizing the learning curve. This innovative solution improves total knee arthroplasty outcomes while offering simple and efficient technology adoption.”

“Knee⁺ NexSight is not just an evolution of our clinically proven technology, it’s a new approach built around the realities of U.S. outpatient care, informed by the expertise of U.S. surgeons and a proven worldwide track record of our earlier solutions,” said Pixee Medical founder and CEO Sébastien Henry.

In February 2024, the company raised $15 million in capital to open a U.S. subsidiary, rapidly deploy a new range of AR navigation platforms, open an office in Singapore, and recruit new talents.