Pixee Medical Surgery Solution Has Received Clearance to Enter U.S. Knee Surgery Market with Vuzix AR M400 Smart Glasses
AREA Member Vuzix who is a leading supplier of Smart Glasses and Augmented Reality (AR) technology and products, today announced that Pixee Medical, a France-based supplier of high-performance computer-assisted surgery solutions, has received 510K clearance from the U.S. 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.
Knee+ is a patented platform designed to assist orthopedic surgeons to perform surgeries better and faster by providing real-time positioning of instruments, directly in their field of view. Knee+ is intuitive and requires minimal training even for those who have never utilized navigation or robots since it does not change the overall technique for 90% of surgeons who use a conventional technique. Knee+ consists of proprietary software using unique computer vision and artificial intelligence algorithms and running on connected Vuzix M400 Smart Glasses, with no bulky capital equipment or disposables required. The solution is simple, accurate and much less expensive than surgical assistance robots.
The United States represents 50% of the worldwide market for knee replacement surgeries, and according to estimates there are more than 30,000 orthopedic surgeons in the U.S who carry out approximately 600,000 total knee replacements annually. Pixee Medical plans to start surgeries as soon as possible in the US with Digitally Augmented Surgeons to prove the efficiency of its breakthrough, affordable, and efficient solution, especially adapted for the growing surgery vertical of ambulatory surgical centers.
“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,” states 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.”
“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 U.S. 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.”