FDA Radiology AI Devices

OTS Hip is a surgical system designed to assist orthopedic surgeons in planning and performing total hip arthroplasty (hip joint replacement) surgeries. It uses CT images of the patient's hip anatomy to create a detailed 3D model, enabling precise preoperative planning and real-time intraoperative navigation. This image-guided system improves surgical accuracy and helps position compatible hip prostheses according to the pre-planned locations, enhancing patient outcomes.

The NuVasive Pulse System is an advanced surgical device designed to assist surgeons during spinal procedures by monitoring neurophysiologic activity and providing enhanced fluoroscopic imaging and navigation. It combines neurophysiologic monitoring to assess nerve function and safety, image enhancement to improve the quality of fluoroscopic images at low doses, and computer-assisted navigation to guide precise placement of spinal implants, helping to improve surgical accuracy and patient outcomes.