Pixee Medical Receives FDA Clearance for Knee+ AR Solution
Pixee Medical, a pioneer in digitally augmented surgery technology, announces that its Knee+ AR computer assisted orthopedic solution has received 510(k) clearance from the U.S. Food and Drug Administration.
Knee+ is a patented platform designed to assist orthopedic surgeons to perform surgeries better and faster by providing real-time positioning of instruments, right in their field of view. Knee+ is intuitive and requires minimal training since it does not change the overall technique for 90% of surgeons who use a conventional technique but have never utilized navigation or robots. Knee+ consists in a proprietary software using unique computer vision and artificial intelligence algorithms and running on connected smartglasses, with no bulky capital equipment or disposables required.
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The first Knee+ surgery was performed in June 2020 in Lariboisière Hospital in Paris. Pixee Medical began commercialization in Europe and Australia in January 2021 and was surprised by just how quickly its product was adopted, with more than 60 systems sold in Q1. The company proved that the market was ready for this innovation and is now expanding rapidly by partnering with leading orthopedic implant companies.
“The FDA’s clearance of Knee+ is an important step forward as the USA represents 50% of the worldwide market. 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.”
“Today, Knee+ is well positioned to help ambulatory surgical centers face the significant backlog and increase in knee surgery. These centers need intuitive, effective, attractive and affordable solutions to meet their patients’ needs, now.”