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Stereotaxis Climbs on FDA Nod

Stereotaxis (NYSE: STXS) began Monday with shares in the green. The company, a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received U.S. Food and Drug Administration 510(k) clearance for the Synchrony™ system.

Synchrony is designed to digitize and modernize the interventional cath lab. Synchrony’s slim and stunning 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 in the future. 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.”

STXS shares gained 13 cents, or 7%, to $2.00.