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BioWorld - Wednesday, April 8, 2026
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Home » FDA greenlights Augmedics’ AR system for spinal surgery
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FDA greenlights Augmedics’ AR system for spinal surgery

Dec. 23, 2019
By Meg Bryant
Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year. While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery.
Medical technology Regulatory Augmented reality Digital health Orthopedics FDA

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