COMPANY

Stereotaxis

FDA-cleared device company Past trials only

Profile checked Oct 10, 2026

Keywords: Ventricular Tachycardia Coronary Artery Disease Supraventricular Tachycardia Congenital Heart Disease Cardiac Arrhythmias Premature Ventricular Contraction Atrial Fibrillation Congestive Heart Failure Cardiac Resynchronization Therapy Cardiac ablation using the MAGiC Ablation Catheter MAGiC™ Epicardial mapping and/or ablation Magnetic irrigated ablation catheter Vdrive Lasso navigation RF Ablation PowerAssert RF wire in crossing coronary in-stent chronic total occlusions Bi-ventricular lead placement

$8.5MRaised (2 yrs)11Trials (company is sponsor)5FDA records (2 yrs)

Timeline

Oct 31, 2026 Trial start —: MAGiC - Congenital Heart DIsease source ↗
Aug 27, 2026 FDA FDA 510(k) clearance: GenesisX RMN — K262744, Aug 27, 2026. Applicant at approval: Stereotaxis, Inc. source ↗
Apr 1, 2026 FDA FDA 510(k) clearance: Synchrony — K253473, Apr 1, 2026. Applicant at approval: Stereotaxis, Inc. source ↗
Jan 5, 2026 FDA FDA PMA approval: MAGiC Ablation Catheter — P240014, Jan 5, 2026. Applicant at approval: Stereotaxis, Inc. source ↗
Nov 6, 2025 FDA FDA 510(k) clearance: Stereotaxis GenesisX RMN with Navigant Workstation (NWS) — K251792, Nov 6, 2025. Applicant at approval: Stereotaxis, Inc. source ↗
Jul 23, 2025 FDA FDA 510(k) clearance: MAGiC Sweep EP Mapping Catheter — K250590, Jul 23, 2025. Applicant at approval: Stereotaxis, Inc. source ↗
Jul 17, 2025 Raise Follow-on offering — Registered direct: $8.5M (initial closing, as published); deal value up to $12.5M (not counted as received), announced Jul 17, 2025. Source: SEC filing. source ↗
Jan 2, 2024 Trial start Not phased (device or behavioral study): The MAGiC™ Cardiac Ablation European Study source ↗
Oct 2, 2020 Trial start —: RMN Versus Manual Epicardial Retrospective PMCF source ↗
2016-01 Trial start Not phased (device or behavioral study): Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population source ↗
2012-08 Trial start Phase 3: Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study source ↗
2011-03 Trial start —: Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study source ↗
2010-03 Trial start Phase 2: PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO) source ↗
2009-10 Trial start Not phased (device or behavioral study): Stereotaxis Computed Tomography (CT) Co-Registration Study source ↗
2009-06 Trial start Phase 4: Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia source ↗
2007-02 Trial start Phase 4: HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study source ↗
2006-06 Trial start Phase 4: MAGNET CRT Feasibility - Efficiency of LV Lead Placement Comparing Conventional vs. Magnetic Guidance source ↗

Upcoming milestones

Dec 31, 2027 (ESTIMATED) · Not phased · The MAGiC™ Cardiac Ablation European Study · NCT06019845
Jan 31, 2029 (ESTIMATED) · · MAGiC - Congenital Heart DIsease · NCT07812818

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $8.5M. Last 2 years.

Jul 17, 2025 Follow-on offering — Registered direct: $8.5M (initial closing, as published); deal value up to $12.5M (not counted as received), announced Jul 17, 2025. Source: SEC filing. source ↗

Clinical trials (lead sponsor) 11

Record	Title	Phase	Status	Start	Primary completion
NCT07812818	MAGiC - Congenital Heart DIsease	Not listed	Not yet recruiting	Oct 31, 2026	Jan 31, 2029 (estimated)
NCT06019845	The MAGiC™ Cardiac Ablation European Study	Not phased (device or behavioral study)	Recruiting	Jan 2, 2024	Dec 31, 2027 (estimated)
NCT04171479	RMN Versus Manual Epicardial Retrospective PMCF	Not listed	Completed	Oct 2, 2020	Mar 30, 2023 (actual)
NCT02637947	Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population	Not phased (device or behavioral study)	Terminated	2016-01	Feb 15, 2022 (actual)
NCT00851279	Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia	Phase 4	Completed	2009-06	2012-10 (actual)
NCT01656772	Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study	Phase 3	Completed	2012-08	2013-12 (actual)
NCT01401608	Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study	Not listed	Terminated	2011-03	2013-12 (actual)
NCT01131793	PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)	Phase 2	Completed	2010-03	2011-03 (actual)
NCT00994331	Stereotaxis Computed Tomography (CT) Co-Registration Study	Not phased (device or behavioral study)	Terminated	2009-10	2011-03 (actual)
NCT00370526	HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study	Phase 4	Terminated	2007-02	2007-04 (actual)
NCT00370474	MAGNET CRT Feasibility - Efficiency of LV Lead Placement Comparing Conventional vs. Magnetic Guidance	Phase 4	Terminated	2006-06	Not listed

FDA records (last 2 years)

Aug 27, 2026 FDA 510(k) clearance: GenesisX RMN — K262744, Aug 27, 2026. Applicant at approval: Stereotaxis, Inc. source ↗
Apr 1, 2026 FDA 510(k) clearance: Synchrony — K253473, Apr 1, 2026. Applicant at approval: Stereotaxis, Inc. source ↗
Jan 5, 2026 FDA PMA approval: MAGiC Ablation Catheter — P240014, Jan 5, 2026. Applicant at approval: Stereotaxis, Inc. source ↗
Nov 6, 2025 FDA 510(k) clearance: Stereotaxis GenesisX RMN with Navigant Workstation (NWS) — K251792, Nov 6, 2025. Applicant at approval: Stereotaxis, Inc. source ↗
Jul 23, 2025 FDA 510(k) clearance: MAGiC Sweep EP Mapping Catheter — K250590, Jul 23, 2025. Applicant at approval: Stereotaxis, Inc. source ↗

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