Stereotaxis’ Synchrony System Gets FDA OK & Launches

Stereotaxis has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Synchrony system.

The company said Synchrony was designed to digitize and modernize the interventional cath lab. Its slim 55” 4K ultra-high-definition display consolidates viewing and control of 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 ultra-low latency to provide clear visualization. Its architecture permits obsolescence protection for labs as new tech is introduced in the future. Synchrony is made available with SynX, a cloud-based, HIPAA and GDPR-compliant app that allows 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.”

Stereotaxis reiterated its guidance of over $3 million in revenue this year from Synchrony systems placed independent of robotic systems. Synchrony and SynX were engineered as foundational platforms for future innovations—the architecture enables future applications and leveraging of 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 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.”

In January, the company earned FDA clearance for its MAGiC catheter, a robotically-navigated magnetic ablation catheter engineered for cardiac ablation procedures.