What’s the current regulatory status (EU/US) and which indications are approved?

Imricor’s Vision-MR Ablation Catheter 2.0, Vision-MR Diagnostic Catheter, Vision-MR Dispersive Electrode, Advantage-MR EP Recorder/Stimulator System, and NorthStar Mapping System hold CE Mark approval for use in Europe. The ablation catheter is indicated for the treatment of typical atrial flutter. The company’s first generation products are cleared for clinical use in the Kingdom of Saudi Arabia. In the United States, Imricor’s ongoing VISABL-AFL IDE study supports future FDA premarket approval for the Vision-MR Ablation Catheter 2.0.

CE Mark:

• Advantage-MR EP Recorder/Stimulator received CE Mark in 2016
• Vision-MR Ablation Catheter (Type I Atrial Flutter indication) and Vision-MR Dispersive Electrode approved in January 2020.
• Vision-MR Diagnostic Catheter received CE Mark in 2023.
• Vision-MR Ablation Catheter 2.0 (Type I Atrial Flutter indication) received CE Mark in 2024.
• NorthStar Mapping System received CE Mark in 2025.

Other markets:

• Saudi FDA approval for capital equipment and consumables noted in 2024.

United States:

• VISABL-AFL IDE trial underway; first iCMR-guided ablation performed at Johns Hopkins (Aug 2024) to support the Vision-MR Ablation Catheter 2.0 Type I Atrial Flutter indication. (FDA premarket approval pending.)

Expanding Indications:

• VISABL-VT clinical trial commenced (April 2025) at Amsterdam University Medical Centre.