FDA Radiology AI Devices

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 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.

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.