FDA Radiology AI Devices

CORIOGRAPH Pre-Op Planning and Modeling Services is a software tool used for preoperative planning of orthopedic surgeries such as unicondylar knee replacement, total knee arthroplasty, and primary total hip arthroplasty. It generates patient-specific bone models and surgical plans based on medical imaging scans, helping surgeons plan and optimize implant placement before surgery.

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 Affera Integrated Mapping System with the Impedance Localization Patch Kit is a computer-based diagnostic tool designed to assist clinicians in catheter-based cardiac electrophysiological mapping. It provides real-time visualization of catheters, maps cardiac signals, and helps guide therapeutic interventions by displaying detailed cardiac maps and signals, enhancing cardiac procedure accuracy and patient care.

The Caduceus S is an augmented reality-based navigation system designed to assist surgeons in accurately placing pedicle screws during percutaneous spine surgery. It leverages intraoperative CT or 2D/3D C-arm imaging and optical tracking, projecting navigation data directly into a headset worn by the surgeon to improve precision and visualization during procedures involving the thoracic and lumbosacral spine.

Vitesse (5.0) is a treatment planning software designed for medical professionals to assist in planning, guiding, optimizing, and documenting high-dose-rate brachytherapy procedures. It supports real-time ultrasound guidance, image import and export via DICOM standards, and visualization of complex imaging data including PET and MR scans. This software helps clinicians create and manage radiation treatment plans accurately and efficiently, improving patient care in radiation therapy.

MIM – Symphony HDR Fusion is an advanced medical imaging software designed to assist trained clinicians with processing and analyzing multiple imaging modalities such as CT, MRI, PET, and ultrasound. It supports fusion and registration of images, contouring of tumors and tissues, and planning for high dose rate brachytherapy treatments. By integrating image visualization, catheter digitization, and dose planning, it helps clinicians optimize radiation therapy for cancer patients safely and effectively.

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 Materialise Shoulder System is a patient-specific medical device designed to assist surgeons in preoperative planning and intraoperative positioning of shoulder replacement components. It includes the SurgiCase Shoulder Planner software, which utilizes CT imaging to generate detailed 3D pre-surgical plans. Based on these plans, patient-specific guides and models are created to help precisely position implants during surgery, improving surgical accuracy and outcomes for total and reverse shoulder arthroplasty.

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.

The Intra-Operative Positioning System (IOPS) by Centerline Biomedical uses a fiducial tracking pad and a guidewire handle for real-time tip positioning and navigation during endovascular interventions. By leveraging 3D vascular models derived from prior CT scans, it helps clinicians accurately guide catheters and guidewires inside the descending aorta as an adjunct to fluoroscopy, enhancing procedure precision without providing a diagnosis itself.