The St. Louis-based developer of surgical robotic technology for minimally invasive endovascular intervention designed its Synchrony platform to digitize and modernize the interventional cath lab. FDA clearance comes about six months after the company submitted Synchrony to the agency. At that time, it also received CE mark for the technology.
Synchrony features a slim, 55” 4K ultra-high-definition display, consolidating the viewing and control of all disparate systems in the lab. It offers an enhanced procedure experience with custom layouts and streamlined workflows. The system also has an intuitive user interface and a decluttered environment.
Stereotaxis says that Synchrony digitizes video streams with full fidelity and less than a single-frame latency for clear visualization. Its architecture allows obsolescence protection for labs as new technologies roll out in the future.
The company offers Synchrony with SynX, a cloud-based HIPAA and GDPR-compliant app. SynX allows for secure, remote connectivity, collaboration, recording and cath lab monitoring.
Matthew Dare, who serves as research and technology coordinator at Texas Cardiac Arrhythmia Institute in Austin, Texas, says the technology offers a “better intraoperative experience for physicians and nurses.” Dare adds that it offers attractive tools for managing cardiovascular programs with remote monitoring, collaboration and recordings.
With clearance, Stereotaxis reiterates its guidance for more than $3 million in Synchrony revenue in 2026.
David Fischel, Stereotaxis chair and CEO, said:
“Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities. 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.”
