Pixee Medical receives 510(k) clearance for knee arthroplasty augmented reality glasses
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Pixee Medical received FDA 510(k) clearance for its Knee+ augmented reality, surgical navigation device for knee arthroplasty, according to a press release.
“The FDA’s clearance of Knee+ is an important step forward as the U.S. represents 50% of the worldwide market. We plan to quickly expand our platform to perform hip and shoulder replacements,” Pixee Medical Founder and CEO Sébastien Henry said in the release.
Pixee Medical, a medical technology manufacturer based in France, began offering Knee+ on the commercial market in Europe and Australia in January 2021.
The Knee+ platform includes augmented reality glasses to assist with implant positioning. The glasses contain a camera to film procedures while displaying navigation information in the surgeon’s line of vision. The proprietary technology requires “minimal training since it does not change the overall technique,” according to the release.
“Our platform is designed to become the cornerstone of data acquisition and exchange during surgery, as well as a plug-and-play hub for accessories like connected instruments, robotic arms and wireless tools,” Henry said.
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