Stereotaxis Secures CE Mark and Files FDA 510(k) for Synchrony System to Digitize Interventional Cath Labs

St Louis, Missouri-based Stereotaxis has announced the European launch and U.S. regulatory submission of its Synchrony™ system, a digital solution aimed at transforming interventional catheterization laboratories. The company received CE Mark certification for Synchrony and submitted a 510(k) application to the U.S. Food and Drug Administration (FDA), marking a significant step toward global commercialization.

Synchrony consolidates the control and visualization of multiple cath lab systems into a single, 55-inch 4K ultra-high-definition display. The system provides real-time, high-fidelity imaging with minimal latency, offering physicians a clearer view during complex cardiac procedures. Its design allows hospitals to streamline workflow, reduce equipment clutter, and future-proof their labs through an adaptable architecture capable of integrating new technologies over time.

The system also connects to SynX™, a secure cloud-based platform compliant with HIPAA and GDPR standards. SynX supports remote collaboration, case recording, and real-time monitoring, enabling physicians to connect across locations for training or procedural support. Experts from major U.S. cardiac centers have noted the system’s potential to improve both intraoperative efficiency and post-procedure management.

Stereotaxis emphasized that Synchrony and SynX are foundational to its broader digital surgery initiative. The technologies are expected to support future applications involving artificial intelligence, automation, and remote robotic procedures. According to CEO David Fischel, the system not only enhances the company’s robotic navigation capabilities but also extends value across all cath labs by enabling more efficient workflows and connected care environments.