FDA Radiology AI Devices

The xvision Spine system by Augmedics Ltd. is an advanced surgical navigation system that helps surgeons precisely locate anatomical structures in the spine during open or percutaneous procedures. By integrating near-eye augmented reality displays with fluoroscopic and CT images, it enables real-time visualization of tracked surgical instruments overlaid on patient anatomy, improving accuracy for procedures such as pedicle screw and iliosacral screw placement. This technology enhances surgical precision and safety, aiding clinicians in complex spine surgeries.

The ARVIS® Shoulder is an AI-powered computer navigation system designed for shoulder replacement surgery. It helps surgeons accurately position implants by using preoperative CT imaging and provides augmented reality visual guidance during the procedure, enhancing surgical precision and patient outcomes.