Stereotaxis Receives CE Mark, Seeks FDA Approval for Synchrony Surgical Robotics System
Benzinga Newsdesk 1 year ago
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Stereotaxis (NYSE:STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE Mark in Europe and submitted a 510(k) application to the FDA in
Stereotaxis (NYSE:STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE Mark in Europe and submitted a 510(k) application to the FDA in the US for the Synchrony™ system.
Synchrony is designed to digitize and modernize the interventional cath lab. Synchrony's slim and stunning 55" 4K ultra-high-definition display consolidates the viewing and control of all disparate systems in the lab, offering an enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment. Synchrony digitizes the video streams with full fidelity and less than a single frame latency, offering crystal-clear visualization. Its architecture allows obsolescence protection for labs as new technologies are introduced in the future. Synchrony is made available with SynX™, a cloud-based HIPAA and GDPR-compliant app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab.