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www.fdanews.com/articles/202561-pixee-medicals-computer-assisted-knee-surgery-platform-cleared
FDA clears text

Pixee Medical’s Computer-Assisted Knee Surgery Platform Cleared

April 30, 2021

The FDA has granted Pixee Medical 510(k) clearance for Knee+, an augmented reality platform designed to help surgeons perform knee surgery.

The system provides real-time positioning of surgical instruments within the surgeon’s field of view and it requires minimal training to use because it does not change the basic technique for most surgeons.

The platform consists of proprietary software using computer vision and artificial intelligence algorithms and connected smart glasses that are worn by the surgeon.

The Besançon, France-based company plans to expand the platform to include hip and shoulder replacements.

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