Stereotaxis bags FDA clearance for next-gen cath lab tech

Stereotaxis bags FDA clearance for next-gen cath lab tech

By: IPP Bureau

Last updated : April 09, 2026 8:28 pm




Stereotaxis, a global leader in surgical robotics for minimally invasive procedures, has announced US FDA clearance for its Synchrony system, a breakthrough designed to modernize interventional catheterization labs.
 
The Synchrony system features a 55-inch 4K ultra-high-definition display that consolidates multiple lab systems into a single, intuitive interface. It offers enhanced visualization with ultra-low latency, streamlined workflows, customizable layouts, and a decluttered environment. 
 
Built for the future, Synchrony’s architecture protects labs from obsolescence and integrates seamlessly with SynX, a HIPAA and GDPR-compliant cloud platform for remote monitoring, collaboration, and recording.
 
“We have long recognized that seamless remote connectivity and collaboration for our EP labs could be very beneficial,” said 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.”
 
Daniel Melby, Medical Director of Electrophysiology Labs at Allina Health Minneapolis Heart Institute, highlighted the system’s practical impact: “We are excited by this technology and the opportunity to be among the first to modernize our catheter labs with Synchrony and SynX."
 
Matthew Dare, CEPS, Research and Technology Coordinator at Texas Cardiac Arrhythmia Institute, praised Synchrony’s advanced capabilities.
 
“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.”
 
Stereotaxis reiterated guidance of over $3 million in revenue this year from Synchrony systems placed independently of its robotic platforms.
 
“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.”

Stereotaxis surgical robotics

First Published : April 09, 2026 12:00 am