Stereotaxis obtains CE mark for Synchrony system, files FDA application

Published 15/10/2025, 12:40
Stereotaxis obtains CE mark for Synchrony system, files FDA application

ST. LOUIS - Stereotaxis (NYSE:STXS), a surgical robotics company focused on minimally invasive endovascular intervention with a market capitalization of $278 million, announced Wednesday it has received CE Mark approval in Europe for its Synchrony system and submitted a 510(k) application to the U.S. Food and Drug Administration. According to InvestingPro data, the company has demonstrated strong growth with revenue increasing nearly 34% over the last twelve months, though currently trading slightly above its Fair Value.

The Synchrony system aims to modernize interventional catheterization laboratories with a 55-inch 4K ultra-high-definition display that consolidates viewing and control of lab systems. According to the company’s press release, the platform offers custom layouts, streamlined workflows, and digitized video streams with minimal latency. Analysts maintain a strong buy consensus on the stock, with price targets ranging from $4 to $5, as revealed by InvestingPro’s comprehensive analysis.

The system is being launched alongside SynX, a cloud-based application that enables secure remote connectivity, collaboration, recording, and monitoring while complying with HIPAA and GDPR regulations.

Matthew Dare, Research and Technology Coordinator at Texas Cardiac Arrhythmia Institute, stated that Synchrony’s "hardware and software architecture is far beyond what anyone else has developed," while Dr. Jim Cheung, Director of Cardiac Electrophysiology Fellowship at Weill Cornell Medicine, noted that SynX "provides a much-needed solution that can permit seamless collaboration across labs."

David Fischel, Stereotaxis Chairman and CEO, described the technology as "central to our digital surgery efforts" and indicated the system could support future capabilities including remote procedures and automated catheter navigation.

The company claims its technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere.

Stereotaxis did not provide a timeline for expected FDA clearance or commercial availability of the system in the U.S. market.

In other recent news, Stereotaxis reported its second-quarter 2025 earnings, revealing a revenue of $8.8 million, which exceeded analyst expectations of $7.75 million. The company also posted an earnings per share of -$0.05, surpassing the forecasted -$0.07. In addition to the earnings report, Stereotaxis and CardioFocus announced a collaboration to develop and commercialize robotic Pulsed Field Ablation technology for cardiac arrhythmias. This partnership merges Stereotaxis’ robotic magnetic navigation systems with CardioFocus’ Centauri PFA System, already used in Europe for over 9,000 patients. Furthermore, Erasmus University Medical Center in Rotterdam successfully completed the first procedures in the Netherlands using Stereotaxis’ Genesis Robotic Magnetic Navigation System. This development marks a significant advancement in robotic magnetic navigation technology for cardiac ablation procedures. These recent developments highlight Stereotaxis’ ongoing efforts to innovate in the field of cardiac arrhythmia treatment.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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