Augmedics Secures FDA Clearance for xvision, an AR Surgical Guidance System

Augmedics, a Chicago-based startup developing surgical virtual reality technologies, received 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.

Clinical support for the 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.
According to Dr. Frank Philips, Professor of Orthopaedic Surgery at Rush, “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.”
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.”
Link: Augmedics homepage…
Via: Augmedics
Original Article: (https://www.medgadget.com/2020/01/augmedics-secures-fda-clearance-for-xvision-an-ar-surgical-guidance-system.html)