Thursday, March 28, 2024

FDA approves augmented reality surgery tool that gives surgeons ‘X-ray vision’

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Right now, augmented reality technology is most commonly associated with gaming or, perhaps, pick and placing your virtual Ikea furniture. But soon it will be used to give surgeons a type of “X-ray vision” when they carry out procedures — and the U.S. Food and Drug Administration (FDA) has just given it the green light.

“The Xvision System is an augmented reality image guidance system, the first of its kind for surgery,” Augmedics CEO Nissan Elimelech told Digital Trends.

Using the Xvision Spine System (XVS), surgeons can visualize the 3D spinal anatomy of a patient while operating. They do this by donning a head-mounted display, which allows them to look directly inside patients — seeing through skin and tissue as if they have superpowers. XVS’s AR provides added data that makes it easier to navigate instruments and implants. This kind of computer-assisted surgery tool can help make minimally invasive surgery possible by providing surgeons with more information on where they need to make incisions.

“We have the same fundamentals as traditional surgical navigation systems, [meaning that] we use reference markers on the patient,” Elimelech explained. “We do a registration with a preoperative or intraoperative CT scan and use an optical tracker. With traditional navigation, though, the surgeon needs to reference all of the information on a distant 2D screen, and will need to look away from the patient to navigate his or her instruments. Our system is different because all of the components are in a lightweight headset. All of the information is displayed in front of him or her, on the patient, in a very real 3D display.”

Beyond line-of-sight issues, the problem with traditional navigation systems for surgeons is that they are bulky and expensive. This translates to low adoption rates. Augmedics hopes that its AR solution can help solve this problem, and in the process make navigation tools a more commonplace part of surgeries everywhere.

“We are starting to take orders for the headsets today, and we expect distribution to start in late first quarter,” Elimelech continued. “The FDA clearance gives us the ability to sell, and bring this technology to hospitals and surgery centers.”

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