BETA
Public medical-device company developing robotic magnetic navigation systems and interventional catheters.
Stereotaxis develops robotic technologies for minimally invasive endovascular intervention. Its magnetic navigation systems steer compatible devices, with an established focus on electrophysiology and treatment of cardiac arrhythmias. The company is publicly traded as STXS and operates from St. Louis, Missouri.
The current and legacy portfolio includes GenesisX, Genesis and Niobe navigation systems, alongside catheter and interventional-device activity. FDA decisions are device-specific; a navigation-system clearance does not authorize every compatible catheter or every proposed procedure.
Company financial disclosures provide a more direct view of commercialization than private-company revenue estimates. Its 2026 updates describe system installations, recurring catheter revenue and expansion into broader endovascular robotics. Acquired businesses, older platforms and development products require separate ownership and regulatory mapping rather than a single undifferentiated portfolio count.
Stereotaxis’ regulatory position extends beyond robotic navigation: MAGiC ablation catheter received original PMA approval P240014 on January 5, 2026 for its specific congenital-heart-disease arrhythmia indication. MAGiC Sweep and Synchrony have separate 510(k) decisions. Company disclosures document U.S. MAGiC use and Synchrony shipments in 2026; the older HELIOS approval remains separate history. [57][53][54][52][51][35][55][1]
The matched FDA history contains 2 distinct recall events: 0 open, 2 terminated. Z-0430-2021 (2020-09-21; terminated): There is a potential for fire in the inside computer cabinet. Z-0590-04 (2004-01-27; terminated): The magnet at the end of the guidewire could break off. [36][37][38][39][40][41][42]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Robotic magnetic navigation for compatible devices; exact compatibility and indicated anatomy depend on labeling. [57][53][54][51]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Earlier-generation robotic magnetic navigation system with compatible catheter advancement. [57][52]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Robotically navigated magnetic interventional ablation catheter for its specific labeled congenital-heart-disease arrhythmia population. [35]
FDA PMA approvedCommercial U.S. use reported in 2026.
Digital operating-room system supporting the electrophysiology workflow. [29]
FDA-clearedInitial orders and shipments reported in 2026.
Magnetically navigated electrophysiology mapping catheter; a separate device from the MAGiC ablation catheter. [27]
Commercial availability not establishedFDA clearance announced in 2025; current U.S. commercial availability not independently established.
The 2026 company disclosures document initial U.S. MAGiC use and Synchrony shipments. Robocath was acquired in July 2026; acquired-platform development and geographic permissions must be distinguished from the existing U.S. navigation/catheter authorizations. [55][57][56][48][46][50][45]
FDA recorded a special 510(k) decision for GenesisX RMN. [54]
Company’s second-quarter update reported completion of the Robocath acquisition. Acquired product families remain outside this selected regulatory mapping. [49]
Company reported $32.4 million in 2025 revenue. This is historical reported revenue, not a 2026 forecast. [47]
FDA recorded the initial reviewed GenesisX decision under K251792. [53]
Accessed 10/20/2026