News | Cath Lab | October 16, 2025

Stereotaxis Synchrony System Gets European CE Mark; Applies for FDA 510(k) Certification

Synchrony is designed to digitize and modernize the interventional cath lab.


Oct. 15, 2025 — Stereotaxis recently announced it has obtained CE Mark in Europe and submitted a 510(k) application to the FDA in the United States for the Synchrony system.

Synchrony is designed to digitize and modernize the interventional cath lab. Synchrony’s slim 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.

“In my role managing the technology across our electrophysiology labs and advising labs across the country, I have significant experience with the various interventional lab display offerings,” said Matthew Dare, CEPS, Research and Technology Coordinator, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. “The underlying hardware and software architecture of Synchrony and SynX is far beyond what anyone else has developed. It promises a better intraoperative experience for physicians and nurses, improved equipment reliability and maintenance, and attractive tools for managing a cardiovascular program with remote monitoring, collaboration and recordings.”

“We have long recognized the importance of remote connectivity and collaboration for our EP labs,” said Dr. Jim Cheung, Professor of Medicine and Director of Cardiac Electrophysiology Fellowship and Research at Weill Cornell Medicine in New York City. “Technologies to date though have not made reliable high-quality connectivity easy. SynX provides a much-needed solution that can permit seamless collaboration across labs and enhance our ability to ensure the best patient care and to train the next generation of physicians.”

Synchrony and SynX have been engineered to be foundational platforms for future innovations. The advanced architecture enables future applications and the leveraging of artificial intelligence for enhanced clinical insights, automation, and safety.

"Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities,” said David Fischel, Stereotaxis Chairman and CEO. “The technology improves the robotic cockpit, and will be critical in supporting future robotic efforts for remote long-distance procedures and automated catheter navigation. The opportunity is much broader than robotic labs as we believe all cath labs stand to benefit from improved workflow, connectivity, and collaboration.”

For more information, please visit www.stereotaxis.com.


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