Cydar EV (Series B) and Cydar EV Maps

Cydar EV Series B is a cloud-based software-as-a-service device cleared by the FDA to assist fluoroscopic X-ray guided endovascular procedures by providing advanced pre-operative planning and intra-operative image guidance. It leverages CT data visualization, vascular segmentation, and real-time image superimposition to enhance operative planning and execution, including new features like virtual guidewire placement.

Cydar EV Series B, also known as Cydar EV Maps, developed by Cydar Ltd., received U.S. FDA 510(k) clearance on December 3, 2021. This regulatory decision deemed the medical device substantially equivalent to existing market products, permitting its marketing for use in fluoroscopic X-ray guided endovascular procedures within the chest, abdomen, and pelvis, provided general controls and potential specific controls are met. The device functions as a software-as-a-service (SaaS) product hosted on cloud servers, designed to enhance endovascular interventions. Its core functionalities include importing and visualizing CT data, segmenting vascular anatomy, creating detailed operative plans, superimposing this planning information onto live fluoroscopic images, and facilitating post-operative review, along with new features like virtual guidewire placement. As a software-only device without patient contact, it has undergone rigorous verification and validation, concluding that its benefits outweigh any associated risks.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the quantitative evidence demonstrating Cydar EV Maps' impact on procedure time, radiation exposure, or contrast agent usage compared to traditional methods?; How does the device's cloud-based architecture ensure data security, privacy, and real-time performance reliability during critical surgical procedures?; Are there specific clinical scenarios or complex anatomical challenges where Cydar EV Maps has shown superior performance or, conversely, identified limitations?; What post-market surveillance or clinical trial data will Cydar Ltd. collect to evaluate the long-term effectiveness and patient outcomes associated with the device's adoption?; How do the new features, such as virtual guidewire placement and enhanced measurement tools, specifically improve procedural accuracy or reduce complications?