FDA Radiology AI Devices

The Paradigm System is a surgical navigation device that helps surgeons accurately place spinal surgical instruments during open procedures. It integrates real-time high-resolution camera images of the surgical site with preoperative CT imagery to create a 3D model of the spine, enabling precise instrument placement and improving surgical accuracy and safety from thoracic to sacrum vertebrae.

The NuVasive Pulse System is a medical device that helps surgeons precisely locate anatomical structures during spinal surgeries using intraoperative 3D imaging and computer-assisted navigation. It tracks surgical instruments in real-time and overlays their virtual positions on patient images, enhancing surgical accuracy and safety in procedures like pedicle screw placement and iliosacral screw placement.

The TMINI Miniature Robotic System is a robotic-assisted surgical device designed to help surgeons accurately plan and execute total knee replacement surgeries. It uses preoperative CT scans to create 3D bone models, allowing precise implant positioning through software planning and robotic guidance. The system enhances surgical accuracy and efficiency by using AI-enhanced image segmentation, intraoperative tracking, and spatial boundary definition during surgery.

The Remex Spine Surgery Navigation Instrument is designed to assist surgeons in precisely positioning surgical tools and spinal implants during spinal surgeries. It works by integrating fluoroscopic and CT images to guide procedures like pedicle screw placement, enhancing surgical accuracy and patient safety.

The Mako Shoulder Application (1.0) is part of the Mako System designed to assist surgeons in reverse shoulder arthroplasty procedures by providing AI-driven, software-defined spatial boundaries using patient CT imaging. It aids in pre-surgical planning, implant placement, and intraoperative navigation, improving surgical accuracy and outcomes.

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.

ARVIS® Shoulder is a computer-assisted surgical navigation system designed to help surgeons precisely position and align implants during total shoulder arthroplasty. It uses preoperative CT scans processed with AI algorithms for automatic image segmentation and anatomical landmark identification, providing real-time measurements during surgery to guide instrument placement and implant positioning, thereby enhancing surgical accuracy and outcomes.

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.

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.

Spine Planning 2.0 is a software tool that helps surgeons plan spinal surgeries using medical images like CT, MR, and X-rays. It uses AI to automatically label vertebrae and suggest spinal implants such as screws and rods, improving accuracy and efficiency during preoperative and intraoperative planning.