France-based medical devices firm Pixee Medical has obtained CE marking certification for its Knee+, an orthopedic navigation system for total knee arthroplasty.
Knee+ is said to be the first orthopedic navigation system that leverages M400 Smart Glasses developed by Vuzix, a supplier of Augmented Reality (AR) technology products.
In addition, the patented technology combines the advanced computer vision and deep learning algorithms to precisely track instruments and implants during surgeries.
Pixee Medical founding president Sébastien Henry said: “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.”
Pixee Medical is expecting a (510k) approval from FDA for the Knee+ by the end of 2020
Unlike bulky and expensive robotic solutions, Knee+ is a simple to use, cost effective device that does not require preoperative DICOM or disposables.
The CE marking certification for Knee+ would allow the commercialisation of the advanced product across the European Union and other CE Mark geographies, with help of implant manufacturers serving as distributors.
Pixee Medical is expecting (510k) approval from FDA for the Knee+ before the end of 2020.
The company has secured more than €2.5m ($2.71m) and won a €1.2m ($1.30m) grant by winning the last French I-Nov contest to support the development of advanced computer assisted orthopedic solutions.
Pixee Medical intends to develop a shoulder implant navigation system, featuring a hologram in the surgeon’s glasses to precisely guide through the skin during a surgical procedure.
Vuzix president and chief executive officer Paul Travers said: “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.”
