Stereotaxis Clears FDA for Synchrony System, Targeting $3M in Standalone Revenue

Event summary

  • Stereotaxis received FDA 510(k) clearance for its Synchrony system on April 6, 2026.
  • The system consolidates interventional cath lab controls into a 55” 4K display with ultra-low latency video streams.
  • Synchrony includes SynX, a cloud-based app for secure remote connectivity and collaboration.
  • Stereotaxis expects over $3M in revenue this year from Synchrony systems sold independently of robotic systems.

The big picture

Stereotaxis’ Synchrony system addresses the growing need for digitization and workflow efficiency in interventional cath labs. The FDA clearance positions the company to capitalize on the broader trend toward remote collaboration and AI-enhanced procedural environments. With over $3M in projected standalone revenue, Synchrony could expand Stereotaxis’ market reach beyond robotic labs, tapping into the larger cath lab modernization market.

What we're watching

Market Adoption
How quickly Synchrony gains traction in non-robotic cath labs, given its standalone revenue potential.
Technological Integration
The pace at which Synchrony’s architecture accommodates future AI and automation applications.
Competitive Positioning
Whether Stereotaxis can leverage Synchrony to solidify its leadership in surgical robotics for endovascular intervention.