Cydar EV
Cydar Ltd.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.
Intended Use
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy from a previously acquired contrast-enhanced diagnostic CT scan onto live fluoroscopic images to assist the positioning of guidewires, catheters, and other endovascular devices during fluoroscopy-guided procedures in the lower thorax, abdomen and pelvis.
Technology
Software-as-a-Service running on cloud servers providing augmented reality enhanced X-ray fluoroscopy images by capturing live fluoroscopy video via external video ports and using machine vision for 2D-3D registration based on vertebral anatomy.
Performance
Non-clinical testing included software verification (registration accuracy, overlay alignment, info security, responsiveness) and software validation (usability, system availability, vessel segmentation). A multicenter clinical study evaluated safety and efficacy, showing the device is safe and effective for its intended use in endovascular procedures.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/15/2016
5 months - 2
FDA Approval
7/7/2016
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