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Home » Stereotaxis wins CE mark for Synchrony system, submits to FDA

Stereotaxis wins CE mark for Synchrony system, submits to FDA

October 15, 2025 By Sean Whooley

Stereotaxis logo

Stereotaxis (NYSE:STXS) announced today that it received CE mark for its Synchrony system while also submitting it to the FDA for 510(k) clearance.

St. Louis-based Stereotaxis designed Synchrony to digitize and modernize the interventional cath lab. It features a slim 55″ 4K ultra-high-definition display to consolidate the viewing and control of all disparate systems in the lab. This helps to deliver an enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface and a decluttered environment.

Synchrony works to digitize 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.

Stereotaxis makes Synchrony available with SynX, a cloud-based, HIPAA- and GDPR-compliant app. It allows for secure remote connectivity, collaboration, recording and monitoring of the cath lab. The advanced architecture enables future applications and the leveraging of AI for enhanced clinical insights, automation and safety.

Matthew Dare serves as research and technology coordinator at Texas Cardiac Arrhythmia Institute in Austin, Texas. He says the technology delivers a better intraoperative experience for physicians and nurses. Dare says it also offers improved equipment reliability and maintenance and attractive tools for managing a cardiovascular program.

“Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities,” said David Fischel, Stereotaxis chair and CEO. “The technology improves the robotic cockpit, and will be critical in supporting future 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.”

Filed Under: Artificial Intelligence (AI), Cardiovascular, Health Technology, Imaging, Machine Learning (ML), Software / IT Tagged With: Stereotaxis

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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