On October 15, 2025, Stereotaxis announced that its Synchrony system received CE Mark approval in Europe, marking the first regulatory clearance for the company’s new digital cath‑lab platform. The Synchrony system features a slim 55‑inch 4K ultra‑high‑definition display that consolidates video streams from all lab equipment into a single, low‑latency interface, improving procedural workflow and operator ergonomics.
The following day, October 16, 2025, Stereotaxis filed a 510(k) application with the U.S. Food and Drug Administration for the same system. The filing positions Synchrony for U.S. market entry and signals the company’s intent to expand its digital surgery ecosystem beyond its existing robotic navigation products.
Synchrony’s architecture includes SynX, a cloud‑based, HIPAA‑ and GDPR‑compliant application that enables secure remote connectivity, collaboration, recording, and monitoring of cath‑lab procedures. By integrating this platform with its robotic systems, Stereotaxis aims to enhance remote‑procedure capabilities and support future AI‑driven clinical insights, potentially creating new recurring revenue streams and strengthening its competitive position in the interventional cardiology market.
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