News | Cath Lab | April 07, 2026

FDA Grants Clearance to Stereotaxis Synchrony System

Synchrony aggregates the viewing and control of all cath lab systems and procedural information onto a single, consolidated, high-resolution display in the procedure and control rooms.

cath lab, ep lab, cloud

Photo: Stereotaxis


April 6, 2026 —Stereotaxis has received U.S. Food and Drug Administration 510(k) clearance for its Synchrony system. Synchrony aggregates the viewing and control of all cath lab systems and procedural information onto a single, consolidated, high-resolution display in the procedure and control rooms.

It 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 ultra-low latency, offering crystal-clear visualization. Its architecture allows obsolescence protection for labs as new technologies are introduced. 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.

“We have long recognized that seamless remote connectivity and collaboration for our EP labs could be very beneficial,” said Dr. Mauricio Arruda, Professor of Medicine at Case Western Reserve University School of Medicine and Director of Electrophysiology at University Hospitals Harrington Heart & Vascular Institute. “We are particularly interested in being early pioneers of Synchrony and SynX, and look forward to demonstrating that intraoperative collaboration enhances our ability to provide the best patient care and train the next generation of physicians.”

“We are excited by this technology and the opportunity to be among the first to modernize our catheter labs with Synchrony and SynX when the Richard M. Schulze Surgical and Critical Care Center at Abbott Northwestern Hospital opens in late August,” said Daniel Melby, MD, Medical Director of Electrophysiology Labs at Allina Health Minneapolis Heart Institute. “Our cardiology labs have become increasingly busy and complex environments, accentuating the value of technology that enhances procedure workflow, improves lab efficiency and encourages collaboration.”

“In my role managing the technology across our electrophysiology labs and advising labs across the country, I have significant experience with 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.”

"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 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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