FDA clears augmented reality smartglasses for guiding knee replacement surgeries

30 April 2021

Conor Hale / FierceBiotech

While most robotic surgery platforms chase precision by making surgeons adopt a wholly new system, Pixee Medical aims to help physicians finesse their own knee replacement procedures with its augmented reality headsets.

Built into a pair of glasses, the newly FDA-cleared Knee+ system uses a camera to help judge the alignment of instruments and the knee joint itself within the surgeon's field of view, without requiring them to change their surgical technique.

Instead, the French developer relies on a series of braces labeled with QR codes that can be read by the camera and tracked in a three-dimensional space.

Manipulating the leg allows for quick acquisition of the mechanical axes between the hip and the knee, while automatically displaying degree-by-degree adjustments in the angle of the joint and planned cuts into the bone.

Pixee Medical launched the system in Europe and Australia in January, after its first knee procedure was completed in Paris last summer. The company had sold more than 60 systems by the end of the first quarter.

The FDA's blessing represents a big commercial step for the company, with the U.S. accounting for half of the worldwide knee replacement market, according to Sébastien Henry, founder and CEO of Pixee Medical.

The company plans to expand its platform to include hip and shoulder replacements, as well as partner up with orthopedic implant manufacturers.

The system is also built to one day integrate with additional accessories, such as connected instruments, robotic arms and wireless tools, Henry said in a statement.

At the same time, the company hopes its AR guidance can help speed up knee procedures on the whole, with 2020’s COVID-19 lockdowns creating a large backlog in deferred surgeries.

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