FDA Clears Stereotaxis’ GenesisX Robotic Navigation System

Stereotaxis has received 510(k) clearance for GenesisX, the newest version of its robotic magnetic navigation system used in catheter-based procedures for cardiac arrhythmias. The upgraded platform addresses installation challenges that limited adoption of earlier models. With magnetic shielding built into the unit, GenesisX no longer requires wall modifications, operates on standard power, and needs no structural anchoring. Its miniaturized electronics and smaller cabinet also support easier integration into existing cardiac catheterization labs.

The clearance was announced a day before the company reported lower third-quarter revenue and a wider net loss. Stereotaxis expects GenesisX to generate stronger demand once fully launched. The system previously received CE marking, and the compatible MAGiC ablation catheter is already available in Europe. The company is expanding its catheter portfolio, including the MAGiC Sweep mapping catheter cleared earlier this year. Stereotaxis is also partnering with CardioFocus to advance a robotic pulsed field ablation solution.

24-11-2025