FDA clears Stereotaxis GenesisX robot that fits in unmodified cath labs
Stereotaxis received FDA 510(k) clearance for GenesisX, its next-generation robotic magnetic navigation system. Physicians use it to steer a magnetic-tipped catheter from a computer during ablation for arrhythmias such as atrial fibrillation. Unlike earlier Stereotaxis systems, GenesisX has magnetic shielding built into the unit rather than the room walls, runs on standard power, needs no structural anchoring and has an 80% smaller cabinet. The company says this lets it be installed in existing cath labs without construction.
Why it's notable: Earlier versions needed a lab rebuilt around the robot, which was a big reason few hospitals adopted robotic navigation for ablation. Removing that requirement makes it a practical option for more EP programs.