FDA Radiology AI Devices

EndoNaut is a medical imaging software system that helps doctors during endovascular procedures by overlaying three-dimensional vessel images from preoperative scans onto real-time two-dimensional fluoroscopy images. This assists clinicians in accurately positioning catheters, guidewires, and stents within blood vessels in areas like the thorax, abdomen, pelvis, and lower limbs, improving procedural outcomes and patient care.

The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is a stereotaxic image-guided navigation system that assists surgeons in performing precise cranial surgery. It provides real-time tracking of instruments, image registration with preoperative scans, and step-by-step guidance for biopsies and ventricular catheter placement, improving surgical accuracy and safety.

The LungVision System is a medical imaging software that helps doctors navigate tools inside the lungs during procedures. It works by segmenting CT scan data and overlaying it on live X-ray images to guide catheter placement accurately, improving procedural safety and effectiveness.

Cydar EV is a cloud-based software that enhances live X-ray fluoroscopy images by overlaying 3D vessel anatomy from preoperative CT scans. This helps clinicians during endovascular procedures by improving guidance for positioning devices like guidewires and catheters, especially in the abdomen, pelvis, and lower thorax.