Israeli developed surgical xvision system receives FDA approval

Yokne’am Illit-based medical-tech company Augmedics recently received US Food and Drug Administration approval for its xvision system.Augmedics founder and CEO Nissan Elimelech told The Jerusalem Post on Monday the xvision system “is the first augmented-reality guidance system for surgery.”At this stage, the headset is to be used for spinal and pelvic surgeries, he said.“Although there are currently other augmented-reality devices used in medicine today, as well as other image guidance systems, this is the first of its kind to combine these two tools to be used during surgery,” Elimelech said. “Other image guidance systems have a separate 2D screen, where the surgeon needs to look away from the patient to see the data, and also bulky equipment that takes up valuable OR space.”However, the xvision headset allows a surgeon to visualize the 3D anatomy of the patient’s spine, through their skin, by looking directly at the patient as if they had “X-ray” vision, he said.“This helps them to accurately place screws and other instrumentation within the spine, and the whole system is contained in a lightweight headset,” Elimelech said.In a statement, Augmedics said the xvision system consists of a transparent near-eye-display headset and all elements of a traditional navigation system.“It accurately determines the position of surgical tools, in real time, and a virtual trajectory is then superimposed on the patient’s CT data,” the company said. “The 3D navigation data is then projected onto the surgeon’s retina using the headset, allowing him or her to simultaneously look at the patient and see the navigation data without averting his or her eyes to a remote screen during the procedure.”The system is designed to revolutionize how surgery is done by giving the surgeon better control and visualization, which may lead to easier, faster and safer surgeries, it said.Asked about how the xvision system will revolutionize surgery in the future, Elimelech said the it will revolutionize surgery in “how it is performed.”It will replace “the current bulky and expensive image guidance systems out there today and increase adoption,” he said.“This is important because we want to put this technology into as many surgeons’ hands as possible and to give them the critical data needed for them to accurately guide their instrumentation during surgery,” Elimelech said. “The lightweight headset allows us to free up OR space and also price the device where it will be easily incorporated into a hospital system.”The medical-tech company, which was founded in 2014, started development of the virtual-reality device five years ago and is constantly improving the system.“We started our first in-human clinical trial in August of 2018 at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center in Israel,” Elimelech said. “We filed with the FDA in April of 2019 and received our clearance in December.”Elimelech told the Post the company is currently selling the system, “and we expect cases to start in early 2020.”He said they will explore “more applications” for the headset “in the future, such as  cranial, ear nose and throat, joints, trauma, [and] any application where image guidance is important for the surgeon.”Frank Phillips, a professor of orthopedic surgery at the Rush University Medical Center, said in the Augmedics statement that “the ability… [that] the xvision provides to visualize the patient’s spinal anatomy in 3D, coupled with live CT images as a retina display, is game-changing.“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,” he said, adding that “the economics of the xvision system are also compelling in both the hospital and the surgicenter environment.”