FDA Radiology AI Devices

The ROSA Knee System is a robotic-assisted surgical device used during total knee replacement surgeries. It helps surgeons precisely place knee implants by using software to define spatial boundaries relative to anatomical landmarks and utilizing a robotic arm to guide bone resections and implant positioning. This system can integrate pre-operative imaging such as X-rays or MRI to plan surgeries more accurately and improve surgical outcomes.

The xvision Spine System by Augmedics Ltd. is an augmented reality-based surgical navigation system designed to aid surgeons in precisely locating anatomical structures during open or percutaneous spine procedures. It combines preoperative CT or intraoperative X-ray imaging with a headset that overlays virtual 3D navigation information directly onto the patient's anatomy in real-time, enhancing surgical accuracy and safety for spine operations such as pedicle screw placement and other spinal trajectories.

Automatic Registration by Brainlab AG is a software tool that facilitates image-guided surgery by automatically registering intraoperatively acquired 3D CT, CBCT, or fluoroscopic images to the surgical environment. This helps surgeons precisely correlate patient images with their anatomy during surgery, improving navigation accuracy and surgical outcomes.