Stereotaxis has gained CE mark approval and submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its Synchrony system.

According to the company, Synchrony aims to digitize and modernize the interventional cath lab. Its 55-inch 4K display consolidates viewing and control of all disparate systems in the lab, offering custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment.

Synchrony digitizes video streams will full fidelity and less than a single frame latency for clear visualization. Stereotaxis said its architecture protects labs from obsolescence as new technologies are introduced in the future.

The technology is available with SynX, a cloud-based, HIPAA and GDPR-compliant app that provides secure remote connectivity, collaboration, recording, and monitoring of the cath lab.

“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.”

Synchony and SynX were engineered as foundational platforms for future innovations. Its advanced architecture, according to the company, allows future applications and leveraging artificial intelligence (AI) 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.”

Earlier this week, Stereotaxis and CardioFocus began a collaboration agreement to move their robotic pulsed field ablation (PFA) technology toward commercialization.