Total knee AI/AR cleared for sales in the US

The FDA has granted 510(k) clearance to a French startup for surgery software that combines AI with augmented reality and computer vision.

Pixee Medical says its Knee+ helps orthopedic surgeons position instruments in real time and within the surgeon’s field of view, facilitating better and faster total knee replacements.

The company says the system has sold briskly in Europe and Australia, where it has caused changes in operating technique among only 10% of surgeons for whom Knee+ represents an introduction to real-time digital assistance.

The system uses smart glasses for its AR interface. CEO Sébastien Henry says Pixee plans to build out its platform for hip and shoulder replacements.

Announcement here, animated video demonstration here.