Augmented reality gains FDA nod, 10k-case milestone in orthopedics, strides in outpatient surgery

Editor's Note

Augmented reality (AR) guidance keeps surging in perioperative practice: Pixee Medical just secured FDA 510(k) clearance for its Knee+ NexSight system for total knee arthroplasty, while Augmedics’ xvision platform has already guided 10,000 US spine surgical procedures and is rolling out a new CT-Fluoro registration upgrade.

According to a Pixee Medical press release dated April 22, Knee+ NexSight translates “robotic-like precision” into a lightweight, wearable display that steers implant alignment to the degree without preop CT or bulky capital equipment. The company says the software works with every primary knee system, removes disposables, and introduces an optional connectivity module for secure data exchange and over-the-air updates—clear concessions to space, cost, and sustainability pressures in ambulatory surgery centers (ASCs).

As detailed in an OrthoSpine News article also dated April 22, the 10,000-patient milestone for Augmedics signals the accelerating adoption of the xvision Spine System, an open-platform headset that projects 3D anatomy into the surgeon’s line of sight. The landmark case at UConn Health capped a 26-state footprint and more than 55,000 pedicle screws placed. Surgeons report high accuracy with lower cognitive load, enabling complex deformity or revision work through less-invasive approaches. Plus, the new CT-Fluoro workflow removes the need for 3D intraop imaging—another barrier for smaller hospitals and ASCs.

Together, the two announcements signal a maturing AR market aimed squarely at outpatient orthopedics. Cost-trimming form factors, compatibility with existing implants, and data-rich connectivity promise to extend advanced navigation beyond high-capital robotics suites. Perioperative leaders should expect sharper implant positioning, reduced radiation, and workflow shifts toward eyewear-based visualization—innovations that will demand updated staff training, sterility protocols, and informatics support but could pay dividends in turnover efficiency and value-based outcomes.