FDA Radiology AI Devices

EndoNaut is a software system designed to aid physicians during fluoroscopy X-ray guided procedures by overlaying preoperative 3D vascular anatomy onto live fluoroscopy images. It assists in accurately positioning surgical tools and endovascular devices in the chest, abdomen, pelvis, neck, and lower limbs for treatments like aneurysm repair and arterial embolization. This image fusion and navigation tool enhances procedural accuracy, although it does not replace the surgeon's judgment and requires real-time imaging confirmation before device deployment.

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.

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.