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CE marking certification allows the commercialization of Knee+ across the European Union.
May 11, 2020
By: Vuzix Corporation
Vuzix Corporation, a supplier of smart glasses and augmented reality (AR) technology and products, announced that Pixee Medical, a France-based medical company, has received CE marking certification for Knee+, the first orthopedic navigation system using augmented reality smart glasses for total knee arthroplasty. The unique patented technology, combining proprietary computer vision and deep learning algorithms, uses Vuzix’ M400 Smart Glasses to precisely track instruments and implants during surgeries. Compared to bulky and expensive robotic solutions, Knee+ is simple to use, cost effective and does not require preoperative DICOM or disposables. “The introduction of the Vuzix M400 Smart Glasses has opened up a new vertical in the medical space for Vuzix. The team at Pixee Medical has created an innovative path to bring the Vuzix M400 Smart Glasses into the operating room to perform knee replacement surgeries,” said Paul Travers, President and CEO at Vuzix. The CE marking certification for Knee+ is a major milestone for Pixee Medical as it allows the commercialization of its innovative product across the European Union and other CE Mark geographies by using implant manufacturers as distributors. Pixee Medical was also granted ISO 13485:2016 certification and is pursuing and expecting U.S. Food and Drug Administration approval (510k) for Knee+ before the end of 2020. “Pixee Medical has developed a device which aims to apply AR to knee and then shoulder surgery, guiding the practitioner through connected glasses, like a GPS. The solution is simple, accurate and much less expensive than surgical assistance robots. We’re excited to work directly with Vuzix AR Smart Glasses to offer this solution to European Union and other CE mark geographies through implant manufacturers and distributors,” commented Sébastien Henry, founding president of Pixee Medical. Pixee Medical raised over 2.5 million euros and won the last French I-Nov contest with a grant of 1.2 million euros in order to support technological breakthroughs in computer assisted orthopedic solutions. The next development for Pixee Medical is a shoulder implant navigation system, which will display a hologram in the surgeon’s glasses to precisely guide him, through the skin, during an operation.
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