Stereotaxis Inc. (STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, announced that the U.S. FDA has granted a 510(k) clearance for its Synchrony system, marking a significant milestone in modernizing interventional catheter laboratories.
The Synchrony system is designed to digitize and streamline the cath lab environment. Featuring a slim 55-inch 4K ultra-high-definition display, Synchrony consolidates disparate systems into one intuitive, offering custom layouts, streamlined workflows, and crystal-clear visualization with ultra-low latency. The system also provides obsolescence protection, ensuring labs remain compatible with future technologies.
Synchrony is paired with SynX, a cloud-based HIPAA and GDPR-compliant application that enables secure remote connectivity, enabling physicians to collaborate seamlessly during operations, improve efficiency, and enhance patient care.
"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." 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.
Daniel Melby, M.D., Medical Director of Electrophysiology Labs at Allina Health Minneapolis Heart Institute added: "Our cardiology labs have become increasingly busy and complex environments, accentuating the value of technology that enhances workflow, improves efficiency and encourages collaboration."
Stereotaxis reiterating guidance of generating over $3 Million in revenue this year from Synchrony systems placed independent of robotic systems. The company emphasized that Synchrony and SynX are foundational platforms for future innovations, including artificial intelligence applications for enhanced clinical insights, automation, and remote robotic procedures.
"This technology improves the robotic cockpit and will be critical in supporting long-distance procedures and automated catheter navigation," said David Fischel, Chairman and CEO of Stereotaxis. "We believe all cath labs stand to benefit from improved workflow, connectivity, and collaborations."
Stereotaxis technology has already been used to treat more than 150,000 patients worldwide, and the launch of Synchrony represents the latest step in its mission to modernize interventional labs with digital surgery solutions.
STXS has traded between $1.54 and $3.59 over the past year. The stock closed Thursday's trading (April 2, 2026) at $1.87, up 1.08%. In pre-market the stock is at $2.02, up 7%.
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