Xvision: An Augmented Reality Surgical Guidance System By Augmedics Gets US FDA Approval
Source: Thailand Medical News Jan 05, 2020 4 years, 3 months, 2 weeks, 5 days, 13 hours, 55 minutes ago
Chicago-based startup,
Augmedics, which developes surgical virtual reality technologies, has received US FDA 510k clearance for its
augmented reality (AR)
xvision system.
Xvision is comprised of a headset that emulates “X-ray vision” during surgery by projecting 3D navigation data onto the surgeon’s retina. Designed using transparent hardware components, the headset allows a surgeon to see the patient along with overlaid navigation data, including the position and trajectory of surgical tools, implants, and patient’s CT data.
Augmedics’ first use case for
xvision is spinal surgeries during which surgeons benefit from improved visualization of the patients’ spinal anatomies.
The clinical support for the FDA approval comes from a percutaneous laboratory study performed at Rush University Medical Center in Chicago to assess the
xvision system’s accuracy. In the study, surgeons positioned ninety three screws in the thoracic and sacro-lumbar spinal regions of five different cadavers. A comparison of actual and virtual screw positions showed an accuracy of 98.9%. These results corroborated previous cadaver accuracy tests performed by surgeons from
Johns Hopkins Medicine (USA), Sheba Tel-Hashomer Medical Center (Israel), and Assaf Harofeh Medical Center (Israel). In-human clinical trials were launched at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center in 2018 and aim to enroll up to 22 patients receiving spinal screw placements. This study will again evaluate screw placement, via independent radiologist review, as well as user experience, via questionnaire.
Dr. Frank Philips, Professor of Orthopaedic Surgery at Rush told
Thailand Medical News, “The efficiency and accuracy this
augmented reality technology enables in placing spinal implants without looking away from the
surgical field as well as the ability to ‘see the spine’ through the skin in minimally invasive procedures, differentiates the
xvision from conventional spinal navigation platforms.”
In terms of business model viability, Dr. Philips adds “The economics of the
xvision system are also compelling in both the hospital and the surgicenter environment.”
Further commenting on the clearance announcement,
Augmedics founder and CEO Nissan Elimelech shared, “
xvision is our first product of many to follow that will revolutionize
surgery, as it gives surgeons the information they need, directly within their working field of sight, to instill technological confidence in the
surgical workflow and help them do their jobs as effectively and safely as possible.”
For more product info, visit:
https://www.augmedics.com/
