May 3, 2021 – Vuzix Corporation, a supplier of smart glasses and augmented reality (AR) technology and products, has today announced that Pixee Medical, a France-based supplier of computer-assisted surgery solutions, has received 510K clearance from the US Food and Drug Administration (FDA) for its Knee+ total knee replacement surgery solution and placed a follow-on Vuzix M400 Smart Glasses order that will more than double the total amount of systems deployed to date by Pixee Medical to ambulatory surgical centers.
Pixee Medical’s Knee+ platform is designed to assist orthopedic surgeons conducting surgeries by providing real-time positioning of instruments, directly in their field of view. The patented platform consists of proprietary software that utilizes computer vision and artificial intelligence algorithms and runs on connected Vuzix M400 Smart Glasses, with no bulky capital equipment or disposables required.
“The FDA’s clearance of Knee+ is an important step forward and we plan to quickly expand our platform to perform hip and shoulder replacements,” stated Sébastien Henry, Founder and CEO of Pixee Medical. “In addition, 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. Vuzix’ M400 Smart Glasses play a vital role within our Knee+ solution.”
According to Vuzix, Pixee Medical plans to start surgeries as soon as possible in the US with ‘Digitally Augmented Surgeons’ to help prove the efficiency of its solution, which the company states is adapted to meet the needs of the surgery vertical of ambulatory surgical centers.
“We are thrilled to see Pixee Medical receive FDA clearance for Knee+ and we look forward to supporting the worldwide distribution of their innovative AR solution, particularly now in the US market, which accounts roughly half of the world’s annual knee surgeries,” said Paul Travers, President and Chief Executive Officer at Vuzix. “The Vuzix M400 Smart Glasses are lightweight, comfortable and completely wireless and their high-performance camera is ideal for reading QR-code markers and precisely calculating the 3D coordinates of the instruments used during Knee+ surgeries.”
Image credit: Vuzix Corporation / Pixee Medical