Stereotaxis Secures FDA Clearance for 55” 4K Synchrony System, Targets $3M Revenue
Stereotaxis gained FDA 510(k) clearance for its Synchrony system, featuring a 55” 4K display that integrates and digitizes cath lab workflows with ultra-low latency video and SynX cloud connectivity. The company reaffirmed guidance for over $3 million in 2026 revenue from standalone Synchrony placements and highlighted AI-enabled future enhancements.
1. FDA Clearance and System Features
Stereotaxis received U.S. FDA 510(k) clearance for its Synchrony system, a digital surgery platform designed to modernize interventional cath labs. Synchrony’s 55” 4K ultra-high-definition display consolidates multiple video streams with ultra-low latency, custom layouts and an intuitive interface while its architecture ensures future-proof obsolescence protection.
2. Early Adopter Hospitals and Clinical Impact
Early pioneers at University Hospitals Harrington Heart & Vascular Institute, Allina Health Minneapolis Heart Institute and Texas Cardiac Arrhythmia Institute plan to implement Synchrony and SynX to enhance intraoperative collaboration, workflow efficiency and training capabilities. SynX offers a HIPAA and GDPR-compliant cloud app for secure remote connectivity, recording and lab monitoring.
3. Revenue Guidance and Future Innovations
The company reiterated its guidance of over $3 million in revenue this year from Synchrony systems placed independent of its robotic platforms. Executives emphasize that Synchrony and SynX form a foundation for forthcoming AI-driven applications aimed at clinical insights, automation, safety and support for remote robotic procedures.