Cydar EV (Series B) and Cydar EV Maps
Cydar Ltd.Cydar EV Series B is a software product that helps clinicians plan and guide endovascular X-ray procedures by overlaying 3D vessel anatomy from preoperative CT scans onto live X-ray fluoroscopy images. It allows measurement, segmentation, and interactive adjustment of vascular maps during surgery, improving accuracy and procedural guidance.
Intended Use
Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy. It is for patients undergoing fluoroscopic X-ray guided endovascular surgery in the chest, abdomen and pelvis who have had a pre-operative CT scan.
Technology
Cydar EV is a software-as-a-service running on cloud servers, which imports CT scans, segments and annotates vascular anatomy, creates operative plans, and overlays preoperative vessel anatomy onto live fluoroscopic images. It provides interactive, non-rigid transformation of anatomy visualization intraoperatively to account for vessel deformation.
Performance
Software verification and validation testing was conducted on all device functions, focusing on modified features. The device passed all predetermined pass/fail tests, demonstrating performance, functionality, and reliability comparable to predicate devices.
Predicate Devices
No predicate devices specified
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