ArthroLense Announces Completion of Initial Pre-Clinical Software and Hardware Evaluation Testing
Author: Arthrolense Communications |
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Categories: General
Arthrolense, Inc., an emerging pioneer in the development of augmented and mixed reality surgical guidance systems, today announced the successful completion of its initial pre-clinical software and hardware evaluation testing for the company’s AR™Knee System.
In concert with the company’s formal development process, in May of 2021 Arthrolense performed a series of functional protocols in a cadaveric setting in order to more fully advance the company’s design history file and subsequently planned FDA 510(k) filing. The results of this evaluation demonstrated the full spectrum of performance capabilities and precision of the technology.
“The Arthrolense AR Knee System has been developed and refined over a multi-year period and harnesses the full power of state of the art graphics processors and imaging technologies,” explained David Backstein, MD, Arthrolense co-founder and Medical Officer. “Our success in Q2-2021 with the laboratory tests positions us to advance rapidly and decisively through a few remaining milestones as we prepare to file our first 510(k) package.”
With its distinct user-centric design and promising clinical utility, the Arthrolense AR Knee is expected to become a widely embraced assistive technology for surgeons performing joint arthroplasty in the ambulatory surgical center (ASC) setting.
Brad Nathan, CEO of Arthrolense-backer Lynx Equity Limited, commented that “Outpatient total joint replacement is the future, and Arthrolense has emerged at the right place and the right time to address the patient and physician needs within ASC institutions. The AR Knee is the first of several in-process R&D programs, and we are excited to help shape the future of orthopedic surgery with our unique, patented solutions.”
About ArthroLense
Based in Toronto, Ontario, ArthroLense, Inc. is a medical technology firm focused on the development and commercialization of hologram-based surgical navigation systems. ArthroLense holds multiple pending and issued patents and develops operating-room based solutions that leverage augmented and mixed reality technology to deliver real-time, actionable datasets to operating physicians. For more information, please email info@arthrolense.net or visit our web portal at www.arthrolense.net.