FDA Clears Stereotaxis Synchrony System for Robotic-Assisted Endovascular Procedures

Stereotaxis has received clearance from the U.S. Food and Drug Administration (FDA) for its Synchrony System, a robotic technology designed to assist in endovascular procedures. The company also announced the official launch of the system, marking a significant milestone in its development and commercialization efforts.

The Synchrony System is intended to provide physicians with enhanced precision and control during minimally invasive vascular interventions. According to Stereotaxis, the system integrates advanced robotics with imaging technologies to improve procedural accuracy while reducing radiation exposure for both patients and medical staff. The FDA’s clearance allows the company to market and distribute the system within the United States. This regulatory approval follows prior announcements regarding clinical evaluations of the technology, which were conducted as part of its development process.

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Date: April 6, 2026

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GOAI